EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/1385/2023 
(POOL/A1/2023/1385/1385 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 1925/2006 of the European Parliament and of 
the Council and Annex II to Directive 2002/46/EC of the European Parliament and of 
the Council as regards iron milk caseinate added to foods and used in the manufacture 
of food supplements  
(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 2  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 1925/2006 of the European Parliament and of 
the Council and Annex II to Directive 2002/46/EC of the European Parliament and of 
the Council as regards iron milk caseinate added to foods and used in the manufacture 
of food supplements  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the  Treaty on the Functioning of the European Union,  
Having regard to Directive 2002/46/EC of the European Parliament and of the Council of 
10 June 2002 on the approximation of the laws of the Member States relating to food 
supplements1, and in particular Article 4(5) thereof , 
Having regard to  Regulation (EC) No 1925/2006 of the European Parliament and of the 
Council of 20 December 2006 on the addition of vitamins and minerals and of certain other 
substances to foods2, and in particular Article 3(3) thereof,  
Whereas:  
(1) Annexes I and II to Regulation (EC) No 1925/2006 establish the list of vitamin and 
mineral substances  which may be added to foods  and the forms  in which they may be 
added . 
(2) Annexes I and II to Directive 200 2/46/EC establish the list of vitamin and mineral 
substances which may be added to food supplements  and the forms in which they may 
be added . 
(3) Commission Implementing Regulation (EU) 2023/9493 authorised iron milk caseinate 
as a novel food  in, among other p roducts,  certain foods and food supplements subject 
to specific conditions . 
(4) During the process of authorisation, on 4 August 2022 , the European Food Safety 
Authority (‘the Authority’) issued a scientific opinion4 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.  
                                                 
1 OJ L 183, 12.7.2002, p. 51.  
2 OJ L 404, 30.12.2006, p. 26.  
3 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) . 
4 EFSA NDA Panel.  Safety of iron milk proteinate as a nov el 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 (5) Iron milk caseinate  was on the basis of that scientific opinion included in the Union 
list of authorised novel foods provided for in the Annex to Commiss ion Implementing 
Regulation (EU) 2017/2470 .5 
(6) The Commission considers  that the Authority’s opinion gives sufficient grounds to 
establish that  the use of iron milk caseinate  as authorized by Commission 
Implementing Regulation (EU) 2023/9496, when used in foods  and food supplements  
as specified therein, and  excluding the use for infants and young children  is not  of 
safety concern  as a source of iron. 
(7) Based on  the Authority’s favourable opinion  and on the authorisation as a novel food 
as set out in Commissio n Implementing Regulation (EU) 2023/949 , iron milk 
caseinate  should be included in  Annex II Directive 2002/46/EC  and in Annex II to  
Regulation (EC) No 1925/2006  as a form of iron. 
(8) The Advisory Group on the Food Chain and Animal and Plant Health  was consulted 
and its comments were taken into consideration.  
(9) Annex II to Directive 2002/46/EC and Annex II to Regulation (EC) No 1925/2006 
should therefore be amended accordingly.  
(10) The measures provided for in this Regulation are in acc ordance with the op inion of the 
Standing  Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex I I to Directive 2002/46/EC is amended in accordance with the Annex to this 
Regulation.  
Article 2  
Annex II to Regulation (EC) No 1925/2006  is ame nded in accordance with the Annex to this 
Regulation.  
Article 3 
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  
                                                 
5 Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union 
list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of 
the Council on novel foods  (OJ L 351, 30.12.2017, p. 72 ). 
6 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) .  
EN 4  EN  Ursula VON DER LEYEN