G/TBT/N/EU/293  
 
19 June 2015  
(15-3173)  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 telephon e 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 Commission 
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/  
3. Notified under Article 2.9.2 [X], 2.10 .1 [ ], 5.6.2 [ ], 5.7.1 [ ], other: 
4. Products covered (HS or CCCN where applic able, 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 
Delegated Regulation supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information 
requirements for food for special medical purposes (13 pages + 8 pages of annex, in 
English) 
6. Description of content: This draft Commission Delegated Regulation lays down rules for 
food for special medical purposes in the EU pursuant to Article 11(1) of Regulation (EU) No 609/2013 of the European Parliament and of th e 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.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Rules for food for special medical purposes are currently laid down in the EU 
by Commission Directive 1999/21/EC, adopted under the framework of Directive 2009/39/EC of the European Parliament and of the Council on foodstuffs intended 
for particular nutritional uses.  
Regulation (EU) No 609/2013 revises the framework applicable to foods intended for 
particular nutritional uses and repeals Directive 2009/39/EC and the legal measures adopted under its framework. It requires th e Commission to adopt delegated acts laying 
down specific compositional and information requirements for the foods under its scope by 
20 July 2015, including food for special medical purposes. 
Regulation (EU) No 609/2013 requires the Commission to take into account the existing 
rules applicable to food for special medical purposes when adopting the relevant delegated 
act. For this reason, this draft delegated Regulation transfers the existing rules of 
Commission Directive 1999/21/EC on food for special medical purposes under the new 
framework of Regulation (EU) No 609/2013 and updates them where relevant on the basis G/TBT/N/EU/293 
 
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  of the consultations carried out with Member States' experts, NGOs and other 
stakeholders. 
Protection of human health or safety 
8. Relevant documents:  
 Codex Standard for the labelling of and claims for foods for special medical purposes 
CODEX STAN 180-1991 
http://www.codexalimentarius.org/dow nload/standards/ 294/CXS_180e.pdf  
 Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special 
medical purposes http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:01999L0021-
20130701&qid=1425994954631&from=EN  
 Regulation (EU) No 609/2013 of the European  Parliament and of the Council of 12 
June 2013 on food intended for infants an d young children, food for special medical 
purposes, and total diet replacement for weight control http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:181:0035:0056:EN:PDF  
9. Proposed date of adoption: September 2015 
Proposed date of entry into force: 20 days from publication in the Official Journal of the 
EU (The provisions shall apply from  3 years after entry into force) 
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 Website: http://ec.europa.eu/growth/tools-databases/tbt/  
https://members. wto.org/crnattachments/2015/TBT/EEC/15_2404_00_e.pdf  
https://members. wto.org/crnattachments/2015/TBT/EEC/15_2404_01_e.pdf