EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11262/2020 
(POOL/E1/2020/11262/11262 -EN.docx)  
[…](2020) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of 
the Council as regards the list of substances that may be added to infant and follow -on 
formula, baby food and processed cereal -based food  
(Text with EEA relevance)   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Article 15 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 lays down 
requirements for the Union list, set out in the Annex to this Regulation , with respect 
to the substance s that may be added to one or more categories of food referred to in 
Article 1(1), which are:  
 infant formula and follow -on formula;  
 processed cereal -based food and baby food;  
 food for special medical purposes;  
 total diet replacement for weight control.  
In order to take into account  the technical progress, scientific developments or the 
protection of consumers' health , Article 16(1) of the Regulation empowers the 
Commi ssion to amend the Annex by means of delegated act s with respect to the 
addition of substan ces to the Union list.  
 2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission consulted the European Food Safety  Authority (EFSA) on the 
matter . EFSA's Scientific Opinion  on Calcium L ‐methylfolate as a source of folate 
added for nutritional purposes to infant and follow‐on formula, baby food and 
processed cereal‐based food2 constitute s the scientific basis for this delegated 
Regulation . 
Member States ’ experts were consulted  in writing  in the context of the Expert Group 
on food intended for in fants and young children, food for special medical purposes 
and total diet replacement for weight control3 between 20 January 2020 and 31 
January 2020 as well as between 26 March 2020 and 10 April 2020 . 
 
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The Union list of substances  that may be added to the specific categories of food 
covered by the scope of Art icle 1(1) of Regulation (EU) No  609/2013  is updated in 
accordance with Article 16 of that Regulation to  authorise the addition of calcium L ‐
methylfolate as a  source of folate  to infant and follow‐on formula, processed cereal -
based food and baby food  on the  basis of EFSA’s advice . 
                                                 
1 OJ L 181, 29.6.2013, p.  35. 
2 EFSA NDA Panel, Scientific Opinion on Calcium l‐methylfolate as a source of folate added for 
nutritional purposes to infant and follow‐on formula, baby food and processed cereal‐based food , EFSA 
Journal doi: 10.2903/j.efsa.2020.5947  
3 Reference E028 93 in the Register of Commission Expert Groups and other similar entities.  EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending the Annex to Re gulation (EU) No 609/2013 of the European Parliament and of 
the Council as regards the list of substances that may be added to infant and follow -on 
formula, baby food and processed cereal -based food  
(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, a nd 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 (E C) No 41/2009 and (EC) No 953/20094, and in particular Article 
16 thereof , 
Whereas:  
(1) The Annex to Regulation (EU) No 609/2013 establishes  a Union list of substances that 
may be added to one or more of the categories of food referred to in Article 1(1)  of 
that Regulation .  
(2) The A nnex to Regulation (EC) No 609/2013 currently  authorises the addition of 
calcium L‐methylfolate as a source of folate to food for special medical purposes  and 
to total diet replacement for weight control .   
(3) Following an application  requesting that the use of calcium L -methylfolate as a source 
of folate is authorised also in infant formula , follow -on formula , processed cereal -
based food and baby food , at the levels necessary to meet the compositional 
requirements for folate set out by the Union legislation for those foodstuffs , the 
Commission requested the European Food Safety Authority  (‘the Authority ’) to 
provide an opinion on the safety and bioavailability of  that substance when added to 
the concerned foodstuffs . In its opinion  of 27 November  20195, the Authority  
concluded that  calcium L -methylfolate is a source from which fola te is bioavailable 
and that it  is safe under the proposed uses and use levels for the target population that 
is infants (<12 months) and young children  (12-<36 months .  
(4) The Commission considers that the Authority’s opinion gives sufficient grounds to 
establish that calcium L -methylfolate  is not of a safety concern as a source of folate 
when used in infant formula , follow -on formula , processed cereal -based f ood and baby 
food at the required levels . Therefore, calcium L -methylfolate  should be included in 
                                                 
4 OJ L 181, 29.6.2013, p.  35. 
5 EFSA NDA Panel, Scientific Opinion on Calcium l‐methylfolate as a source of folate added for 
nutritional purposes to infant and follow‐on formula, ba by food and processed cereal‐based food , EFSA 
Journal , doi: 10.2903/j.efsa.2020.5947 . EN 3  EN the list set out in Annex to Regulation (EC) No 609/2013, as a source of folate in those 
categories of food s. 
(5) Regulation (EC) No 609/2013 should therefore be amended accordingly.  
HAS ADOPTED THIS REGULATION:  
Article 1  
The Annex to Regulation (EU) No 609/2013 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 pu blication 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  
 Ursula VON DER LEYEN