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
Date: 2025-10-08
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: baby food, consumer information, dietary product, food safety, foodstuff, labelling, marketing standard, nutritional needs, product designation








L_202502017EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/2017


12.12.2025







            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
(Text with EEA relevance)


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).




ANNEX
Annexes I, II and III to Delegated Regulation (EU) 2016/127 are amended as follows:






(1)


in Annex I, point 2.3 is replaced by the following:






‘2.3.


Infant formula manufactured from protein hydrolysates
Infant formula manufactured from protein hydrolysates shall comply with the protein-related requirements provided under point 2.3.1, point 2.3.2, point 2.3.3, point 2.3.4 or point 2.3.5.










2.3.1.


Protein-related requirements group A










2.3.1.1.


Protein content






Minimum


Maximum




0,44  g/100  kJ


0,67  g/100  kJ




(1,86  g/100  kcal)


(2,8  g/100  kcal)














2.3.1.2.


Protein source
Demineralised sweet whey protein derived from cows’ milk after enzymatic precipitation of caseins using chymosin, consisting of:






(a)


63 % caseino-glycomacropeptide free whey protein isolate with a minimum protein content of 95 % of dry matter and protein denaturation of less than 70 % and a maximum ash content of 3 %; and










(b)


37 % sweet whey protein concentrate with a minimum protein content of 87 % of dry matter and protein denaturation of less than 70 % and a maximum ash content of 3,5 %.














2.3.1.3.


Protein processing
Two-stage hydrolysis process using a trypsin preparation with a heat-treatment step (from 3 to 10 minutes at 80 to 100 °C) between the two hydrolysis steps.










2.3.1.4.


Indispensable and conditionally indispensable amino acids and L-carnitine
For an equal energy value, infant formula manufactured from protein hydrolysates must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section B of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine may be added together if the methionine: cysteine ratio is not greater than 2, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine: phenylalanine ratio is not greater than 2. The ratio of methionine: cysteine and of tyrosine: phenylalanine may be greater than 2, provided that the suitability of the product concerned for infants is demonstrated in accordance with Article 3(3).
The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal).










2.3.2.


Protein-related requirements group B










2.3.2.1.


Protein content






Minimum


Maximum




0,55  g/100  kJ


0,67  g/100  kJ




(2,3  g/100  kcal)


(2,8  g/100  kcal)














2.3.2.2.


Protein source
Whey protein derived from cows’ milk, consisting of:






(a)


77 % acid whey, coming from whey protein concentrate with a protein content of 35 to 80 %;










(b)


23 % sweet whey, coming from demineralised sweet whey with a minimum protein content of 12,5 %.














2.3.2.3.


Protein processing
The source material is hydrated and heated. Following the heat-treatment step, the hydrolysis is carried out at a pH of 7,5 to 8,5 and a temperature of 55 to 70 °C with the use of an enzyme mixture of a serine endopeptidase and a protease/peptidase complex. The food enzymes are inactivated in a heat treatment step (from 2 to 10 seconds at 120 to 150 °C) during the production process.










2.3.2.4.


Indispensable and conditionally indispensable amino acids and L-carnitine
For an equal energy value, infant formula manufactured from protein hydrolysates must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section A of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine may be added together if the methionine: cysteine ratio is not greater than 2, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine: phenylalanine ratio is not greater than 2. The ratio of methionine: cysteine and of tyrosine: phenylalanine may be greater than 2, provided that the suitability of the product concerned for infants is demonstrated in accordance with Article 3(3).
The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal).










2.3.3.


Protein-related requirements group C










2.3.3.1.


Protein content






Minimum


Maximum




0,45  g/100  kJ


0,67  g/100  kJ




(1,9  g/100  kcal)


(2,8  g/100  kcal)














2.3.3.2.


Protein source
Whey protein derived from cows’ milk, consisting of 100 % sweet whey protein concentrate with a minimum protein content of 80 %.










2.3.3.3.


Protein processing
The source material is hydrated and heated. Prior to the hydrolysis, the pH is adjusted to 6,5–7,5 at a temperature of 50–65 °C. The hydrolysis is carried out with the use of an enzyme mixture of a serine endopeptidase and a metalloprotease. The food enzymes are inactivated in a heat treatment step (from 2 to 10 seconds at 110 to 140 °C) during the production process.










2.3.3.4.


Indispensable and conditionally indispensable amino acids and L-carnitine
For an equal energy value, infant formula manufactured from protein hydrolysates must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section A of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine may be added together if the methionine: cysteine ratio is not greater than 2, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine: phenylalanine ratio is not greater than 2. The ratio of methionine: cysteine and of tyrosine: phenylalanine may be greater than 2, provided that the suitability of the product concerned for infants is demonstrated in accordance with Article 3(3).
The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal).










2.3.4.


Protein-related requirements group D










2.3.4.1.


Protein content






Minimum


Maximum




0,57  g/100  kJ


0,67  g/100  kJ




(2,4  g/100  kcal)


(2,8  g/100  kcal)














2.3.4.2.


Protein source
Whey protein derived from cow’s milk, consisting of 100 % sweet whey protein concentrate with a minimum protein content of 70 %.










2.3.4.3.


Protein processing
The source material is hydrated and heated. Following the heat-treatment step, the hydrolysis is carried out at a pH of 7,0 to 8,0 and a temperature of 50 to 60 °C, using a two-stage hydrolysis process with the use of a serine endopeptidase and a metalloprotease. The food enzymes are inactivated by heat treatment (at 100 to 120 °C for at least 30 seconds) during the production process.










2.3.4.4.


Indispensable and conditionally indispensable amino acids and L-carnitine
For an equal energy value, infant formula manufactured from protein hydrolysates must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section A of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine may be added together if the methionine: cysteine ratio is not greater than 2, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine: phenylalanine ratio is not greater than 2. The ratio of methionine: cysteine and of tyrosine: phenylalanine may be greater than 2, provided that the suitability of the product concerned for infants is demonstrated in accordance with Article 3(3).
The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal).










2.3.5.


Protein-related requirements group E










2.3.5.1.


Protein content






Minimum


Maximum




0,48  g/100  kJ


0,67  g/100  kJ




(2,0  g/100  kcal)


(2,8  g/100  kcal)














2.3.5.2.


Protein source
Whey protein derived from cow’s milk, consisting of 100 % whey protein concentrate with a minimum protein content of 80 %.










2.3.5.3.


Protein processing
The source material is hydrated and heated. Following the heat-treatment step, the pH is adjusted to 7 to 8, at a temperature of 50 to 70 °C, using a two-stage hydrolysis process with the use of serine endopeptidases. The food enzymes are inactivated by heat treatment (at 80 to 90 °C for 25 to 35 minutes) during the production process.










2.3.5.4.


Indispensable and conditionally indispensable amino acids and L-carnitine
For an equal energy value, infant formula manufactured from protein hydrolysates must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section A of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine may be added together if the methionine:cysteine ratio is not greater than 2, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine: phenylalanine ratio is not greater than 2. The ratio of methionine: cysteine and of tyrosine: phenylalanine may be greater than 2, provided that the suitability of the product concerned for infants is demonstrated in accordance with Article 3(3).
The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal).’;














(2)


in Annex II, point 2.3 is replaced by the following:






‘2.3.


Follow-on formula manufactured from protein hydrolysates
Follow-on formula manufactured from protein hydrolysates shall comply with the protein-related requirements provided under point 2.3.1, point 2.3.2, point 2.3.3, point 2.3.4 or point 2.3.5.










2.3.1.


Protein-related requirements group A










2.3.1.1.


Protein content






Minimum


Maximum




0,44  g/100  kJ


0,67  g/100  kJ




(1,86  g/100  kcal)


(2,8  g/100  kcal)














2.3.1.2.


Protein source
Demineralised sweet whey protein derived from cows’ milk after enzymatic precipitation of caseins using chymosin, consisting of:






(a)


63 % caseino-glycomacropeptide free whey protein isolate with a minimum protein content of 95 % of dry matter and protein denaturation of less than 70 % and a maximum ash content of 3 %; and










(b)


37 % sweet whey protein concentrate with a minimum protein content of 87 % of dry matter and protein denaturation of less than 70 % and a maximum ash content of 3,5 %.














2.3.1.3.


Protein processing
Two-stage hydrolysis process using a trypsin preparation with a heat-treatment step (from 3 to 10 minutes at 80 to 100 °C) between the two hydrolysis steps.










2.3.1.4.


Indispensable and conditionally indispensable amino acids
For an equal energy value, follow-on formula manufactured from protein hydrolysates must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section B of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine and the concentration of phenylalanine and tyrosine may be added together.










2.3.2.


Protein-related requirements group B










2.3.2.1.


Protein content






Minimum


Maximum




0,55  g/100  kJ


0,67  g/100  kJ




(2,3  g/100  kcal)


(2,8  g/100  kcal)














2.3.2.2.


Protein source
Whey protein derived from cows’ milk, consisting of:






(a)


77 % acid whey, coming from whey protein concentrate with a protein content of 35 to 80 %;










(b)


23 % sweet whey, coming from demineralised sweet whey with a minimum protein content of 12,5 %.














2.3.2.3.


Protein processing
The source material is hydrated and heated. Following the heat-treatment step, the hydrolysis is carried out at a pH of 7,5 to 8,5 and a temperature of 55 to 70 °C with the use of an enzyme mixture of a serine endopeptidase and a protease/peptidase complex. The food enzymes are inactivated in a heat treatment step (from 2 to 10 seconds at 120 to 150 °C) during the production process.










2.3.2.4.


Indispensable and conditionally indispensable amino acids
For an equal energy value, follow-on formula manufactured from protein hydrolysates must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section A of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine and the concentration of phenylalanine and tyrosine may be added together.










2.3.3.


Protein-related requirements group C










2.3.3.1.


Protein content






Minimum


Maximum




0,45  g/100  kJ


0,67  g/100  kJ




(1,9  g/100  kcal)


(2,8  g/100  kcal)














2.3.3.2.


Protein source
Whey protein derived from cows’ milk, consisting of 100 % sweet whey protein concentrate with a minimum protein content of 80 %.










2.3.3.3.


Protein processing
The source material is hydrated and heated. Prior to the hydrolysis, the pH is adjusted to 6,5–7,5 at a temperature of 50–65 °C. The hydrolysis is carried out with the use of an enzyme mixture of a serine endopeptidase and a metalloprotease. The food enzymes are inactivated in a heat treatment step (from 2 to 10 seconds at 110 to 140 °C) during the production process.










2.3.3.4.


Indispensable and conditionally indispensable amino acids
For an equal energy value, follow-on formula manufactured from protein hydrolysates must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section A of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine and the concentration of phenylalanine and tyrosine may be added together.










2.3.4.


Protein-related requirements group D










2.3.4.1.


Protein content






Minimum


Maximum




0,57  g/100  kJ


0,67  g/100  kJ




(2,4  g/100  kcal)


(2,8  g/100  kcal)














2.3.4.2.


Protein source
Whey protein derived from cow’s milk, consisting of 100 % sweet whey protein concentrate with a minimum protein content of 70 %.










2.3.4.3.


Protein processing
The source material is hydrated and heated. Following the heat-treatment step, the hydrolysis is carried out at a pH of 7,0 to 8,0 and a temperature of 50 to 60 °C, using a two-stage hydrolysis process with the use of a serine endopeptidase and a metalloprotease. The food enzymes are inactivated by heat treatment (at 100 to 120 °C for at least 30 seconds) during the production process.










2.3.4.4.


Indispensable and conditionally indispensable amino acids
For an equal energy value, follow-on formula manufactured from protein hydrolysates must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section A of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine and the concentration of phenylalanine and tyrosine may be added together.










2.3.5.


Protein-related requirements group E










2.3.5.1.


Protein content






Minimum


Maximum




0,48  g/100  kJ


0,67  g/100  kJ




(2,0  g/100  kcal)


(2,8  g/100  kcal)














2.3.5.2.


Protein source
Whey protein derived from cow’s milk, consisting of 100 % whey protein concentrate with a minimum protein content of 80 %.










2.3.5.3.


Protein processing
The source material is hydrated and heated. Following the heat-treatment step, the pH is adjusted to 7 to 8, at a temperature of 50 to 70 °C, using a two-stage hydrolysis process with the use of serine endopeptidases. The food enzymes are inactivated by heat treatment (at 80 to 90 °C for 25 to 35 minutes) during the production process.










2.3.5.4.


Indispensable and conditionally indispensable amino acids
For an equal energy value, follow-on formula manufactured from protein hydrolysates must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section A of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine and the concentration of phenylalanine and tyrosine may be added together.’;














(3)


in Annex III, the introductory sentence under Section A is replaced by the following:

                        ‘For the purposes of points 2.1, 2.2, 2.3.2, 2.3.3, 2.3.4 and 2.3.5 of Annexes I and II, the indispensable and conditionally indispensable amino acids in breast milk, expressed in mg per 100 kJ and 100 kcal, are the following:’.







ELI: http://data.europa.eu/eli/reg_del/2025/2017/oj
ISSN 1977-0677 (electronic edition)