(fra kommisjonsforordningen)

(1) Commission Delegated Regulation (EU) 2016/1276 lays down specific compositional requirements for infant and follow-on formula manufactured from protein hydrolysates. It provides that infant and follow-on formula manufactured from protein hydrolysates are to comply with the requirements for protein content, protein source, protein processing, as well as with the requirements for indispensable and conditionally indispensable amino acids and L-carnitine as set out in point 2.3 of Annex I and in point 2.3 of Annex II to that Regulation. 

(2) In its opinion of 24 July 2014 on the essential composition of infant and follow-on formulae7 , the European Food Safety Authority (‘the Authority’) noted that the safety and suitability of each specific formula containing protein hydrolysates has to be established by clinical evaluation in the target population. So far, the Authority has positively evaluated four protein hydrolysates used in infant and follow-on formulae. The composition of those four protein hydrolysates is included in the requirements currently set out in Delegated Regulation (EU) 2016/127. However, those requirements may be updated in order to allow the placing on the market of a formula manufactured from protein hydrolysates with a different composition from those already positively assessed, following their evaluation by the Authority of their safety and suitability. 

(3) On 3 June 2021, the Commission received a request from Fonterra Co-operative Group Ltd for the evaluation by the Authority of the safety and suitability of two products, an infant and follow-on formula, manufactured from a specific protein hydrolysate, the composition of which did not comply with the requirements laid down in point 2.3 of Annex I and in point 2.3 of Annex II to Delegated Regulation (EU) 2016/127. 

(4) Upon request from the Commission, the Authority adopted a scientific opinion on 28 November 2024 on the nutritional safety and suitability of that specific protein hydrolysate in infant and follow-on formula8 . In that opinion, the Authority concluded that the specific protein hydrolysate as described in the opinion is a nutritionally safe and a 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 0,48 g/100 kJ (2,0 g/100 kcal) protein and complies with the remaining compositional criteria set out in Delegated Regulation (EU) 2016/127 and with the amino acid pattern contained in Section A of Annex III to that Regulation. 

(5) Taking into account the Authority’s conclusions, it is appropriate to allow the placing on the market of infant and follow-on formula manufactured from the specific protein hydrolysate, by adding ‘Protein-related requirements group E’ to the existing compositional requirements for protein hydrolysates set out in Delegated Regulation (EU) 2016/127. 

(6) Delegated Regulation (EU) 2016/127 should therefore be amended accordingly,