EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11723/2017 
(POOL/E1/2017/11723/11723 -EN.doc)  
[…](2017) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Commission Delegated Regulation (EU) No 2016/127 with regard to protein 
requirements for follow -on formula  
(Text with EEA relevance)    
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 orde r to update, amongst others, 
Commission Delegated Regulation (EU)  No 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 fo r 
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 Commission Delegated Regulation (EU)  
No 2016/127 by lowering the minimum protein content required in that Regulation 
for follow -on formula based on cows' milk or goats' milk protein to 1.6 g/100 kcal 
(0,38 g/100 kJ) . 
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission consulted the  European Food Safety Authority (EFSA) on the 
matter. EFSA's Scientific Opin ion on the safety and suitability for use by infants of 
follow -on formulae with a protein content of at least 1.6 g/100 kcal3 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. The written  consultation of the Expert 
Group was carried out between 30 June 2017 and 6 September 2017 . 
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  Delegated Regulation (EU) No 2016/127 taking into 
account relevant technical and scientific progress . 
The proposed changes to Delegated Regulation (EU) No 2016/127 relate to the 
minimum  protein content required in that Regulation for follow -on formula based on 
cows' milk or goats' milk protein that are reduced on the basis of EFSA's advice.  
                                                 
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 Dietetic Products, Nutrition and Allergies),  2017 , Scientific Opinion 
on the safety and suitability for use by infants of follow -on formulae with a protein content of at least 
1.6 g/100 kcal. EFSA Journal 2017;15(5):47 81. 
4 Reference E02893 in the Register of Commission Expert Groups and other similar entities.   
EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Commission Delegated Regulation (EU) No 2016/127 with regard to protein 
requirements for follow -on formula  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to th e 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) Commi ssion Delegated Regulation (EU) 2016/1276 lays down inter alia compositional 
and labelling rules for infant formula and follow -on formula . 
(2) Delegated Regulation (EU) 2016/127 specifically provides for follow -on formula 
manufactured from cow 's milk or goat 's milk proteins to  contain at least 1.8 g 
protein/ 100 kcal (0.43 g/100kJ).  
(3) The Commission received a request from a food business operator f or the placing on 
the market of a follow -on formula based on intact protein from cow's milk with a 
protein content of at least 1.61  g/100  kcal, which is below the permitted levels of 
Directive 2006/141/EC and Delegated Regulation (EU) 2016/127.   
(4) On request  from the Commission, the European Food Safety Authority issued a 
scientific opinion on 5 April 2017 on the safety and suitability for use by infants of 
follow -on formula e with a protein content of at least 1.6 g/100 kcal7. The European 
Food Safety Authori ty concluded that  the use of follow -on formula, based on intact 
protein from cow's milk or from goat's milk , with a protein content of 1.6 g/100 kcal 
(0.38 g/100 kJ ) and otherwise complying with the requirements of the relevant Union 
rules , is safe and suitable for healthy infants living in Europe with an intake of 
complementary foods of a sufficient quality. On the basis of that opinion, and in order 
to foster the development of innovative products, the minimum protein content 
required under  Delegated Regulation (EU) 2016/127 for follow -on formula  based on 
cow's milk or goat's milk protein  should be lowered to 1.6 g/100 kcal.  
                                                 
5 OJ L 181, 29.6.2013, p. 35.  
6 Commi ssion Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation 
(EU) No 609/2013 of the European Parl iament and of the Council 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 feeding , OJ L 25, 2.2.2016, p. 1.  
7 EFSA J ournal 2017;15(5):4781 .  
EN 3  EN (5) Annex II to Delegated Regulation (EU) 2016/127 should th erefore be amended 
accordingly.  
HAS ADOPTED THIS REGULATION : 
Article 1  
Annex II to Commission Delegated Regulation (EU) No 2016/127 is 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,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER