EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2344/2022 
(POOL/A1/2022/PLAN_2344/2344 -
EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Directive 2002/46/EC of the European Parliament and of the 
Council as regards iron hydroxide adipate tartrate 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 Directive 2002/46/EC of the European Parliament and of the 
Council as regards iron hydroxide adipate tartrate 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,  
Whereas:   
(1) Annexes I and II to Directive 2002/46/EC  establish the list of vitamin and mineral 
substances, and for each of them the fo rms, which may be used in the m anufacture of 
food supplements.  
(2) Pursuant t o Article 14 of Directive 2002/46/EC, provisions on vitamin and mineral 
substances in food supplements that may have an effect upon publ ic health are to be 
adopted after consultation with the European Food Safety Authority (‘the Authority’).  
(3) Following a request from the European Commission to deliver an opinion on iron 
hydroxide adipate t artrate  as a novel food pursuant to Regulation (EU) 2015/2283  of 
the European Parliament and of the Council2 and as a source of iron in the context of 
Directive 2002/46/EC, on  27 October 2021  the Authority adopted a scientific o pinion 
on the matter3.  
(4) It follows from that opinion that iron hydroxide adipate  tartrate used in food 
supplements is not of safety concern provided that certain conditions are respected 
which are set out in Commissi on Implementing Regulation (EU) 2022/1373 .4 Based 
on the Authority’s favourable opinion and on the authorisation as novel food 
ingredient as set out in Implementing Regulation (EU) 2022/1373, iron hydroxide 
adipate tartrate  should be included in the list set out in Annex II to Directive 
2002/46/EC in order to allow its use as a source of iron in food supplements.  
                                                 
1 OJ L 183, 12.7.2002, p. 51.  
2 Regulation (EU) 2015/2283 of the Parliament and of the Council of 25 November 2015  on novel foods, 
amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing 
Regulation (EC) No 258/97 of  the European Parliament and of the Council and Commission Regulation 
(EC) No 1852/2001  (OJ L 327, 11.12.2015, p. 1 ). 
3 EFSA NDA Panel. Safety of iron hydroxide adipate tartrate as a novel food  pursuant to Regulation 
(EU) 2015/2283 and as a source of  iron in the context of Directive 2002/46/EC , EFSA Journal 
2021;19(12):6935.  
4 Commission Implem enting Regulation (EU) 2022/1373 of 5 August  2022 authorising the placing on the 
market of iron hydroxide adipate tartrate as a novel food and amending Implementing R egulation (EU) 
2017/2470  (OJ L 206, 8.8.2022, p. 28 ).  
EN 3  EN (5) Directive 2002/46/EC should therefore be amended accordingly.  
(6) The measures provided for in this Regulation are in acc ordance with the opinion of the 
Standing  Committee on the Food Chain and Animal Health,  
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 
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