On November 28, 2020, the European Food Safety Authority scientific committee delivered their opinion on the “Nutritional safety and suitability of a specific protein hydrolysate derived from whey protein concentrate and used in an infant and follow‐on formula” by Danone Trading ELN 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 scope of the scientific report data analysis highlights the following:
- The assessment does not cover safety of the food enzymes used in the manufacture of the protein hydrolysate.
- The protein hydrolysate under evaluation is sufficiently characterized with respect to the fraction of the hydrolyzed 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 by infants for 3.5 months led to growth equivalent to a formula manufactured from intact cow's milk protein (2 g protein/100 kcal).
- No experimental data have been provided on the nutritional safety and suitability of this protein source in follow‐on formula.
- When consumed with complementary foods and the protein source is considered 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
FSA concludes that the protein hydrolysate under evaluation is a nutritionally safe and suitable protein source for use in infant and follow‐on formula with minimum of 2.3 g/100 kcal protein and complies with the compositional criteria of Commission Delegated Regulation (EU) 2016/127 and the amino acid pattern in its Annex IIIA.