Commission updates requirement for protein and protein hydrolysates in infant formulas
European Union
Oct 11, 2024
With implementing Regulation (EU) 2024/2684 of 2 February 2024, the Commission amending Delegated Regulation (EU) 2016/127 as regards the protein-related requirements for infant and follow-on formula manufactured from protein hydrolysates.
On 6 December 2019, the Commission received a request from FrieslandCampina Nederland B.V. 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.
Upon request from the Commission, the Authority issued a scientific opinion on 18 July 2023 on the nutritional safety and suitability of that infant and follow-on formula (4). In that opinion, the Authority concluded that the protein hydrolysate in question 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 0,57 g/100 kJ (2,4 g/100 kcal) protein and complies with the other 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.
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 as described in the opinion. Therefore, the requirements for protein hydrolysates set out in Regulation (EU) 2016/127 should be updated and adapted to also include the requirements for the specific protein hydrolysate as described in the opinion.
Annexes I, II and III to Delegated Regulation (EU) 2016/127 should therefore be amended accordingly.
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