EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11481/2018 CIS 
(POOL/E1/2018/11481/11481 -EN 
CIS.doc)  
[…](2018) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Commission Delegated Regulation (EU) 2016/127 with regard to vitamin D 
requirements for infant formula and erucic acid requirements for infant formula and 
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 order to update, 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 compositional and information requirements for 
infant formulae and follow -on formulae and as rega rds requirements on information 
relating to infant and young child feeding2. 
This delegated Regulation aims to amend Commission Delegated Regulation (EU)  
2016/127 by lowering the m aximum vitamin D content  for infant formula and by 
lowering the maximum level of erucic acid  for infant formula and follow -on formula .  
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 ions on the update of the tolerable up per intake level 
for vitamin D for infants3 as well as on erucic acid in feed and food4 constitute 
respectively the scientific basis for the requirements  on vitamin D  and erucic acid in 
the delegated Regulation . 
Member States' experts were consulted in the  context of the  meeting of the  Expert 
Group on food intended for infants and young children, food for special medical 
purposes and total diet replacement for weight control5 of 11 June 2018 . Additional 
written consultation  of the Expert Group w as carried out between  15 June 2018 and 
2 September 2018.  
Other stakeholders were consulted on the subject in writing in the context of the 
Advisory Group on the Food Ch ain and Animal and Plant Health6 between 
18 October 2018 and 30 October 2018 . One comment  was provided by an industry 
association indicating potential  technical difficulties in  manufacturing infant 
formulae  in line with  the proposed requirements for vitamin D.  Concerns expressed 
with regard to the l atter disregarded EFSA`s scientific opinions with resp ect to the 
safety aspects of the products concerned. Due to safety considerations as well as 
considering the probability of non -compliance together with the tolerances that may 
be permitted for v itamin D values declared on the label , such concerns could no t be 
taken  into account.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The legal basis of the delegated Regulation is Article 11(2) of Regulation (EU) 
No 609/2013 . According to that provision , read in conjunction with Article 11(1) and 
                                                 
1 OJ L 181, 29.6.2013, p. 35.  
2 OJ L 25, 2.2.2016, p. 1.  
3 EFSA Journal 2018;16(8):5365, 118 pp.  
4 EFSA Journal 2016;14(11):4593, 173 pp . 
5 Reference E02893 in the Register of Commission Expert Groups and other similar entities.  
6 Reference E00860 in the Register of Commission Expert Groups and other similar entities.  EN 2  EN 1(1) of Regulation (EU) No  609/2013 , the Commission is empowered to adopt 
delegated acts in order to update  the specific compositional requirements applicable 
to infant formula and follow -on formula  which are laid down in Delegated 
Regulation (EU) 2016/127. The empowerment is subjec t to the general requirements 
set out in Article 6 and 9 thereof and taking into account relevant technical and 
scientific progress.  
The proposed changes to Delegated Regulation (EU)  2016/127 relate to the  reduction 
of the maximum  vitamin D  content permitted  for infant  formula  and the lowering of 
the maximum content of erucic acid  in infant formula and follow -on formula.  EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Delegated Regulation (EU) 2016/127 with regard to vitamin D requirements 
for infant formula and erucic acid requirements for infant formula and follow -on 
formula  
(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 953/20097, and in part icular 
Article  11(2) thereof,   
Whereas:  
(1) Commi ssion Delegated Regulation (EU) 2016/1278 lays down inter alia compositional 
and labelling rules for infant formula and follow -on formula . 
(2) Delegated Regulation (EU) 2016/127 specifically provides for infant form ula to 
contain vitamin D at amounts in the range  2–3 μg/100 kcal . 
(3) Concerns have been raised that high consu mption of formula containing 3 μg/100 kcal 
of vitamin D , combin ed with additional vitamin D intakes through supplementation,  
could lead some infants to consume vitamin D at amounts that could pose  safety risks. 
In order to ensure the highest level of protection of infants, the Commission requested 
the European Food Safety Authority  ('the Authority') to assess the safety of 
consumption by infants of for mulae containing 3 μg/100 kcal of vitamin D . 
(4) In its Scientific Opinion of 28  June 2018 on the update of the tolerable upper intake 
level for  vitamin D for infants ,9 the Authority  concluded that  the use of infant formula  
containing v itamin D at 3 μ g/100 kca l may lead some infants aged up to 4 months to  
consume amounts of v itamin D above t he tolerable  upper  intake level  from the 
formula  alone.  
(5) That opinion also concluded that the use of a maximum vitamin D content of 
2.5 μg/100 kcal in infant formula  does not result in i ntakes of vitamin D above the  
tolerable upper intake level  from the formula alone. On the basis of that opinion , the 
                                                 
7 OJ L 181, 29.6.2013, p. 35.  
8 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 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.  
9 EFSA Journal 2018; 16(8):5365 ,118 pp . EN 4  EN maximum  vitamin D  content  permitted under Delegated Regulation (EU) 2016/127 for 
infant formula  should be lowered to  2.5 μg/100 kcal , in accordance  with Article 6 and 
paragraphs (1) to (4) of Article 9 of Regulation (EU) No 609/2013 .  
(6) Maximum levels for eruci c acid in infant formulae and follow -on formulae have been 
established by Delegated Regulation  (EU) 2016/127 .  
(7) The Authority  has adopted a scientific opinion on the presence of erucic acid in feed 
and food.10 That opinion concluded  that the 95th percentile  dietary exposure level was 
highest in infants and other children which may indicate a risk for young individuals 
with high erucic acid exposure.  
(8) Taking into account the conclusions of the opinion, it is appropriate to lower the  
maximum levels of erucic acid in infant formula and follow -on formula . 
(9) Annex es I and Annex II to Delegated Regulation (EU) 2016/127 should th erefore be 
amended accordingly , 
HAS ADOPTED THIS REGULATION : 
Article 1  
Annex es I and II 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,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER  
                                                 
10 EFSA Journal 2016;14(11):4593, 173 pp .