EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/1886/2023 
(POOL/A1/2023/1886/1886 -EN.docx)  
[…](2023) 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 to allow the use of iron milk caseinate as a source of iron in total diet 
replacement for weight control and in food for special medical purposes, excluding 
infants and young children  
(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 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 provides that  
certain types of substances may be added to one or more of th ose categories of food 
only if those substance s are included in the Union list that is set out in the Annex . 
In order to take into account  the technical progress, scientific developments or the 
protection of consumers' health , and subject to the general requirements set out in  
Articles 6 and 9 of Regulation (EU) No 609/2013 , 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 substances to the Union list.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE ACT  
The Commission consulted the European Food Safety  Authority ( ‘the Authority’ ) on 
the matter . The Authority 's Scientific Opinion  on the safety of iron milk proteinate as 
a novel food pursuant to  Regulation (EU) 2015/2283 and bioavailability of iron f rom 
this source in the context of Directive 2002/46/E C2 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 infants and young children, food for special medical purposes 
and total diet replacement for weight control3 between 23 March  2023 and 15 April 
2023.  
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 Regulation (EU) No  609/2013  as set out in its Article 1(1) is 
updated in accordance with Article 16 of that Regulation and on the  basis of the 
above -mentioned Authority’s opinion  to authorise the addition o f iron milk caseinate 
as a source of iron to total diet replacement for weight control and food for special 
medical purposes . 
                                                 
1 OJ L 181, 29.6.2013, p. 35.  
2 EFSA Journal 2022;20(9):7549  
3 Reference E02893 in the Register of Commission Expert Groups and other similar entities.   
EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of 
the Council to allow the use of iron milk caseinate as a source of iron in total diet 
replacement for weight control and in food for special me dical purposes, excluding 
infants and young children  
(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 92/5 2/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 
16(1) thereof,  
Whe reas:  
(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) Commission Implementing Regulation (EU) 2023/9492 authorised the use of iron milk 
caseinate as a novel food in, among other products, food for special medical purposes 
excluding infants and young children and total diet replacement for weight control, 
subject to certain conditions .  
(3) During the process of authorisatio n, on 4 August 2022 , the European Food Safety 
Authority (‘the Authority’) issued a scientific opinion3 where it concluded that iron 
milk caseinate is safe under the proposed conditions of use and that it is a source from 
which iron is bioavailable.   
(4) The Co mmission considers that the Authority’s opinion gives sufficient grounds to 
establish that iron milk caseinate , as authorized by Regulation (EU) 2023/949,  is not 
of safety concern as a source of iron when used in food for special medical purposes , 
excludin g infants and young children  and in total diet replacement for weight control, 
Therefore, it is appropriate to allow the use of  iron milk caseinate as a source of iron in 
                                                 
1 OJ L 181, 29.6.2013, p.  35. 
2 Commission Implementing Regulation (EU) 2023/949 of 12 May 2023 authorising the placing on the 
market of iron milk caseinate as a novel food and amending Implementing Regulation (EU) 2017/2470 
(OJ L 128, 15.5.2023, p. 60) . 
3 EFSA NDA Panel. Safety of iron milk proteinate as a novel food pursuant to Regulation (EU) 
2015/2283 and bioavailability of iron from this source in the context of Directive 2002/46/EC, EFSA 
Journal 2022;20(9):7549.   
EN 3  EN food for special medical purposes , excluding infants and young children  and in total 
diet replacement for weight control.   
(5) That substance should therefore be included in the Union list of substances that may 
be added to certain categories of food . 
(6) The Annex to Regulation (EU) 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 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  
 Ursula VON DER LEYEN