EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/534/2022 
(POOL/E1/2022/534/534 -EN.docx)  
[…](2022) 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)  
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 that 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 consulted 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  HIPP -Werk Georg Hipp OHG (dossier 
submitted by meyer.science GmbH)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 
intended for infants and young children, food for special medical purposes and total diet 
replacement for weight control4 between 22 April 2022 and 23 June 2022 . 
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 Annex es 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 ), 2022 . 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 HIPP -Werk Georg Hipp 
OHG (dossier submitted by meyer.science GmbH)  EFSA Journal 2022;20(3):7141 . 
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 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 953/20091, and in particular 
Article  11(2) thereof,   
Wher eas: 
(1) Commission Delegated Regulation (EU) 2016/1272 lays down , amongst other  things , 
specific compositional requirements  for infant formula and follow -on formula 
manufa ctured from protein hydrolysate s. It provides that infant formula 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 Delegated Regulation (EU) 2016/127 , in 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 est ablished by clinical evaluation  in 
the target population. So far,  the Authority has evaluated posit ively two protein 
hydrolysates used in infant and follow -on formula e. The composition of those two 
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 composition different from th ose already positively assessed, following a case -
by-case evaluation by the Authority of their safety and suitabili ty.  
                                                 
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 compos ition of infant and follow -on formulae. EFSA Journal 2014;12(7):3760 .  
EN 3  EN (3) On 6 February  2019, the Commission received a request from  meyer.science GmbH , 
on behalf of HIPP -Werk Georg Hipp OHG  and Arl a Foods Ingredients , for the 
evaluation by the Authority of the safety and suitability 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 9 
March 2022  on the  nutritional 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 an infant and 
follow -on formula, as long as the formula in which it is used contains a minimum of 
0.45 g/100 kJ ( 1.9 g/100 kcal) protein and complies with the other compositional  
criteria set out in Delegated Reg ulation (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 Authority’s conclusions, 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 hydrolysates set out in 
Regulation (EU) 2016/127  should be updated  and adapted  to include  also the 
requirements for that protein  hydrolysate .  
(6) Annexes I, II and III to Delegated Regulation (EU) 2016/127 should th erefore be 
amended accordingly.  
Delegated Regulation (EU) 2016/127 appli es to infant and follow -on formula 
manufactured from protein hydrolysates as of 22 Februa ry 2022 . In order to allow  the 
placing on the market of  infant and follow‐on formula manufactured from hydrolysed 
protein in accordance with the requirements 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 ), 2022. 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 HIPP -Werk Georg Hipp 
OHG (dossier submitted by meyer.science GmbH) EFSA  Journal 2022;20(3):7141.   
EN 4  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN