G/TBT/N/EU/951  
3 February 2023  
(23-0758) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
European Commission  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
European Comm ission,  
EU-TBT Enquiry Point,  
Fax: +(32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tbt/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CC CN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Food 
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Regulation 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 (3 pages, in English), (annex - 2 pages, in English)  
6. Description of content:  This draft Commission Regulation conce rns the authorisation of 
the addition of Iron Hydroxide Adipate Tartrate, as a source of iron to food supplements 
in line with EFSA's relevant scientific opinion.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The proposed measure aims at allowing the addition of Iron Hydroxide 
Adipate Tartrate as a source of iron to food supplements. The draft measure reflects the 
favourable outcome of the safety assessment by EFSA. In order to allow the addition of  
the substance to food supplements it is necessary to amend Annex II to Directive 
2002/46/EC on food supplements; Protection of human health or safety  
8. Relevant documents:   
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 supplements  
http://eur -lex.europa.eu/JOHtml.do?uri=OJ:L:2002:183:SOM:EN:HTML  
Safety of iron hy droxide 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  G/TBT/N/EU/951  
 
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  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 
(europa.eu)  
9. Proposed date of adoption:  3rd quarter 2023  
Proposed date of entry into force:  The proposed measure shall enter into force on the 
20th day following its publication in the Official Journal of the EU.  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
European Commission,  
EU-TBT Enquiry Point,  
Fax: + (32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
The text is available on the EU -TBT Website : http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_0893_00_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_0893_01_e.pdf