Commission Delegated Regulation (EU) 2025/2017 of 8 October 2025 amending Delegated Regulation (EU) 2016/127 as regards the protein-related requirements for infant and follow-on formula manufactured from protein hydrolysates

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (1), and in particular Article 11(2) thereof,

Whereas:

(1) Commission Delegated Regulation (EU) 2016/127 (2) 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 formulae (3), 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 Cooperative 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 formula (4). 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,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes I, II and III to Delegated Regulation (EU) 2016/127 are amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 8 October 2025.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 181, 29.6.2013, p. 35, ELI: http://data.europa.eu/eli/reg/2013/609/oj.

(2) Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding (OJ L 25, 2.2.2016, p. 1, ELI: http://data.europa.eu/eli/reg_del/2016/127/oj).

(3) EFSA NDA Panel (2014). Scientific Opinion on the essential composition of infant and follow-on formulae (https://www.efsa.europa.eu/en/efsajournal/pub/3760).

(4) EFSA NDA Panel (2025). Nutritional safety and suitability of a specific protein hydrolysate manufactured by Fonterra Cooperative Group Ltd derived from a whey protein concentrate and used in infant formula and follow-on formula (EFSA Journal, 2025:23(1):e9160, https://doi.org/10.2903/j.efsa.2025.9160).