EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11294/2021 
(POOL/E1/2021/11294/11294 -EN.docx)  
[…](2021) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Delegated Regulation (EU) 2016/127 as regards the protein requirements for 
infant and follow -on formula manufactured from protein hydrolysates  
(Text with EEA relevance)   EN 2  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 order to update  the delegated acts adopted  pursuant to Article 11(1) 
of that Regulation, namely , amongst others, 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 compos itional 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 c onsulted the Euro pean Food Safety Authority (`Authority`) on the matter. 
The Authority` s Scientific Opin ion 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 Danone Trading ELN 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 food 
inten ded for infants and young children, food for special medical purposes and total diet 
replacement for weight control4 between 29 March 2021 and 16 April 2021 . 
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) 2016/127 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 relate  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 ), 2020 . 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 pr otein by D anone Trading ELN 
B.V. EFSA Journal 2020;18(11):6304 . 
4 Reference E02893 in the Register of Commission Expert Groups and other similar entities.  EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Delegated Regulation (EU) 2016/127 as regards the protein 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 953/20095, and in particular 
Article  11(2) thereof,   
Whereas:  
(1) Commission Delegated Regulation (EU) 2016/1276 lays down , amongst others, 
specific compositional requirements  for infant formula and follow -on formula 
manufa ctured from protein hydrolysate s. 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 a s 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 point 2.3 of Annex II to that Regulation .  
(2) As stated in the recitals of Delegated Regulation (EU) 2016/127 , 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 est ablished by 
clinical evaluation  in the target population. The Authority further stated  that only one 
formula containing partially hydrolysed whey protein ha d been positively  evaluated by 
the Authority so far.  The composition of the formula evaluated by the Authority 
corresponds to the requ irements currently set out in Delegated Regulation (EU) 
2016/127. However, those requirements may be updated in order to all ow the placing 
on the market of formula manufactured from protein hydrolysates with a composition 
different from the one already positively assessed, following a case -by-case evaluation 
of their safety and suitability by the Authority .  
                                                 
5 OJ L 181, 29.6.2013, p. 35.  
6 Commi ssion Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementin g 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 ). 
7 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 4  EN (3) On 20 September 2019, the Commission received a request from Danone Trading 
ELN B.V . for the evaluation by the Authority of the safety and suitabili ty of  an infant 
and follow -on formula manufactured from a protein hydrolysate , the composition of 
which does not comply with the requirements laid down in point  2.3 of Annex I and 
point 2.3 of Annex II to Delegated Regulation (EU) 2016/127.  
(4) Upon request from the Commission, the Authority i ssued a scientific opinion on 28 
November 2020  on the  nutritional safety and suitability of the specific protein 
hydrolysate  derived from whey protein concentrate and used in an infant and follow‐
on formula manufactured from hydrolysed pr otein by Danone Trading ELN B.V .8 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 con tains a minimum of 0.55 g/100 kJ (2.3 g/100 kcal) protein and 
complies with the other compositional  criteria set out in Delegated Regulation (EU) 
2016/127 and with the amino a cid pattern contained in Section A of Annex III to that 
Regulation.  
(5) Taking into account the conclusions of the Authority’s  opinion  of 2020 , it is 
appropriate to allow the placing on the market  of infant and follow -on formula 
manufactured from the protein hydrolysate in question . Therefore, the requirements  
for protein hydr olysates set out in Regulation (EU) 2016/127  should be updated  and 
adapted  to include  also the requirements concerning this protein hydrolysate .  
(6) Delegated Regulation (EU) 2016/127 provides that its provisions on infant and follow -
on formula manufactured f rom protein hydrolysates are to  apply from 22 Februa ry 
2022 . In order to allow infant and follow‐on formula manufactured from hydrolysed 
protein in accordance with the requirements set out in this Regulation to remain in the 
market from that date,  this Regulation should enter into force as a matter of urgency .  
(7) Annexes I,  II and III  to Delegated Regulation (EU) 2016/127 should th erefore 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 should 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.  
                                                 
8 EFSA NDA Panel ( EFSA Panel on Nutrition, Novel Foods and Food Allergens ), 2020. 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 pr otein by D anone Trading ELN 
B.V. EFSA Journal 2020;18(11):6304 . EN 5  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN