EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/1709/2023 
(POOL/A1/2023/1709/1709 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Article 11(2) of 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 control1 empowers the European Commission 
to adopt delegated acts in accordance with Article 18 of t hat Regulation, in order to update  the 
delegated acts adopted pursuant to Article 11(1) thereof, such as  Commission Delegated 
Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation  (EU) No 
609/2013 as regards the specific compositional and information requirements for infant 
formulae and follow -on formulae and as regards requirements on information relating to 
infant and young child feeding2. 
This delegated Regulation aims to amend Delegated Regulation (EU)  2016/127  by amending 
the requirements set out by that Regulation for the protein content, protein source, protein 
processing and protein quality for infant and follow -on formula manufactured from 
hydrolysates.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission consul ted the Euro pean Food Safety Authority (the ‘Authority’) on the 
matter. The Authority` s scientific 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 manufactured from hydrolysed protein by FrieslandCampina Nederland B.V.3 
constitutes the scientific basis for the requirements in this delegated Regulation . 
Member States' experts were consulted in writing in the context of the Expert Group on foo d 
intended for infants and young children, food for special medical purposes and total diet 
replacement for weight control4 between 27 July 2023 and 07 September 2023.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The legal basis of this delegated Regulation is Article 11(2) of Regulation (EU) No  609/2013. 
According to that provision , the Commission is empowered to adopt delegated acts in order to 
update the delegated acts adopted pursuant to Article 11(1) of that Regulation, such as 
Delegated Regulation (EU) 201 6/127 subject to the general requirements set out in Article 6 
and 9 thereof, to the additional requirements of Article 10, and taking into account relevant  
technical and scientific progress.  
The proposed chang es to Delegated Regulation (EU) 2016/127 relat e to the update of the 
compositional requirements for infant and follow -on formula manufactured from protein 
hydrolysates laid down in Annexes I and II of that Regulation following the Authority`s 
positive assessment of a protein hydrolysate.  
 
                                                 
1 OJ L 181, 29.6.2013, p. 35.  
2 OJ L 25, 2.2.2016, p. 1.  
3 EFSA NDA Panel ( EFSA Panel on Nutrition, Novel Foods and Food Allergens ), 2023. Nutritional 
safety and suitability of a specific protein hydrolysate derived from whey protein concentrate and used 
in an infant  formula  and follow‐on formula manufactured from hydrolysed pr otein by 
FrieslandCampina Nederland B.V.  EFSA Journal 2023;21(7):8063 . 
4 Reference E02893 in the Register of Commission Expert Groups and other similar entities.   
EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Delegated Regulation (EU) 2016/127 as regards the protein -related 
requirements for infant and follow -on formula manufactured from pr otein 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 i ntended 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 953/20091, and in particular 
Article  11(2) thereof,   
Whereas:  
(1) Commission Delegated Regulation (EU) 2016/1272 lays down  specific compositional 
requirements for infant formula and follow -on formula manufactured from protein 
hydrolysates. It provides that infant formula and follow -on formula manufactured 
from protein hydrolysates are to comply with the requirements  for protei n 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) As stated in Delegated Regulation (EU) 2016/127, i n its opinion of 24 July 2014 on 
the essential composition of infant and follow -on formulae3, 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 three protein 
hydrolysates used in infant and follow -on formulae. The composition of th ose three 
protein hydrolysates  is reflected 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 th ose already positively assessed, following a case -
by-case evaluation by the Authority of their safety and suitability .  
                                                 
1 OJ L 181, 29.6.2013, p. 35.  
2 Commi ssion 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 ). 
3 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion 
on the essential composition of infant and follow -on formulae. EFSA Journal 2014;12(7):3760 .  
EN 3  EN (3) 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 A nnex II to Delegated Regulation 
(EU) 2016/127.  
(4) Upon request from the Commission, the Authority issued a scientific opinion on 18 
July 2023  on the n utritional safety and suitability of that infant and follow -on 
formula4. 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.  
(5) Taking into account the Authority’s conclusion s, 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.  
(6) Annexes I, II and III to Delegated Regulation (EU) 2016/127 should th erefore be 
amended accordingly.  
(7) Delegated Regulation (EU ) 2016/127 applies to infant and follow -on formula 
manufactured from protein hydrolysates as of 22 February 2022. In order to allow the 
placing on the market of infant and follow‐on formula manufactured from hydrolysed 
protein in accordance with the requir ements set out in this Regulation without 
unnecessary delay, this Regulation should enter into force as a matter of urgency,  
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 day  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.  
                                                 
4 EFSA NDA Panel ( EFSA Panel on Nutrition, Novel Foods and Food Allergens ), 2023. Nutritional 
safety and suitability of a specific protein hydrolysate derived from whey protein concentrate and used 
in an infant  formula  and follow‐on formula manufactured from  hydrolysed pr otein by 
FrieslandCampina Nederland B.V. EFSA Journal 2023;21(7):8063 .   
EN 4  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN