EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11174/2016 
(POOL/E1/2016/E1/11174/11174 -
EN.doc)  
[…](2017) 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 lists of substances that may be added to processed cereal -
based food and baby food and to food for special medical purposes  
(Text with EEA relevance)    
EN 2   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 substances 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 purpos es; 
 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 
Commission to amend the Annex by the means of delegated act with respect to the 
addition of substances to the Union list.  
In accordance with Article 22 of the Regulation, the Annex will apply from the date 
of application of the delegated acts concerned, adopted pursuant to Article  11. 
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission consulted the European Food Safety Authority (EFSA) on the 
matters. EFSA's Scientific Opinions on ferrous bisglycinate as a source of iron for 
use in the manufacturing of foods and in food supplements2 and on calcium 
phosphoryl oligosaccharides (POs -Ca®) as a source of calcium added for nutritional 
purposes to food, food supplements and foods for special medic al purposes3 
constitute 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 infants and young children, food for special medical purposes 
and total die t replacement for weight control4 between 30 August 2016 and 
14 September 2016.  
Written consultation with relevant stakeholders was carried out in the context of the 
Advisory Group on the Food Chain and Animal and Plant Health5 between 
16 September 2016 an d 12 October 2016. No comments were received from 
stakeholders.  
                                                 
1 OJ L 181, 29. 6.2013, p. 35.  
2 EFSA AFC Panel (EFSA Scientific Panel on food additives, flavourings, processing aids and materials 
in contact with food) related to Ferrous bisglycinate  as a source of iron for use in the manufacturing of 
foods ad in food supplements, EFSA Journal 10.2903/j.efsa.2006.299 . 
3 EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food), 2016, 
Scientific Opinions on Calcium phosphyoryl oligosaccharides (POs -Ca®) as a source of calcium added 
for nutritional purposes to food, food supplements and foods for special medical purposes, EFSA 
Journal doi: 10.2903/j.efsa.2016.4488 . 
4 Reference E02893 in the Register of Commission Expert Groups and other similar entities.  
5 Reference E00860 in the Register of Commission Expert Groups and other similar entities.   
EN 3   EN 3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
With respect to 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, the Union list shall be updated in accordance with Article 16 of that 
Regulation to  authorise the addition of ferrous bisglycinate , as a source of iron to 
processed cereal -based food and baby food  and of calcium phosphoryl 
oligosaccharides , as a source of calcium to food intended for special medical 
purposes  on the basis of EFSA’s advices.   
EN 4   EN 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 lists of substances that may be added to processed cereal -
based food and baby food and to food for special medical purposes  
(Text with EEA relevan ce) 
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, f ood for special 
medical purposes, and total diet replacement for weight control and repealing Council 
Directive 92/52/EEC, Commissions 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 C ouncil and 
Commission Regulations (EC) No 41/2009 and (EC) No 953/20096, 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) . In 
accordance with Article 22 of that Regulation, the Union list  will apply from the date 
of application of the delegated acts concerned, adopted pursuant to Article 11 of the 
same Regulation . The Union list may be amended  in accordance with  the requirements 
laid down in Article 16 of that Regulation.  
(2) In its Opinion  of 6 January 20067, the European Food Safety Authority  (the Authority)  
concluded that the use of ferrous bisglycinate, as a source of iron in foods intended for  
the general population, food supplements, and foods for particular nutritional uses 
including foods intended for infants and young children does not present a safety 
concern.  
(3) Ferrous bisglycinate  was not included in the Annex to Regulation (EU) No  609/201 3 
for use , as a source of iron , in processed cereal -based food and baby food pending the 
review of the rules applicable to these products. As this review requires  further on 
going scientific assessments  that will not be concluded in the short term, it is not 
appropriate , in the light of  good administrative practices, to further delay the update of 
the Union list as regards the inclusion of  ferrous bisglycinate, as a source of iron  in 
processed cereal -based food and baby food . 
(4) Following an applicatio n, the Commission requested the Authority to provide an 
opinion on the safety and bioavailability of calcium phosphoryl oligosaccharides 
                                                 
6 OJ L 181, 29.6.2013, p.  35. 
7 EFSA AFC Panel (EFSA Scientific Panel on food additives, flavourings, p rocessing aids and materials 
in contact with food) related to Ferrous bisglycinate as a source of iron for use in the manufacturing of 
foods ad in food supplements, The EFSA  Journal (2006) 299, 1 -17.  
EN 5   EN (POs -Ca®) , as a source of calcium added for nutritional purposes to food, food 
supplements and foods for special medica l purposes. In its Opinion  of 26 April8, the 
Authority  concluded that there is no safety concern for the use of this substance in the 
mentioned categories of food  provided that certain conditions detailed in its opinion 
are respected . The Authority noted t hat this substance would be a major contributor to 
the overall average daily intake of calcium.  
(5) The Annex to Regulation (EC) No 609/2013, should therefore be amended 
accordingly.  
(6) The i nterested parties were consulted and the comments  provided  were taken into 
consideration.  
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 tha t 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 JUN CKER  
                                                 
8 EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food), 2016, 
Scientific Opinions on Calcium phosphyoryl oligosaccharides (POs -Ca®) as a source of calcium added 
for nutritional purposes to food, food supplements and foods for spec ial medical purposes, EFSA 
Journal 2016;14(6):4488 .