G/TBT/N/EU/229  
 
5 August 2014  
(14-4568)  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:  eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/enterprise/tbt/  
3. Notified under Article 2.9.2 [ X ], 2.10.1 [   ], 5.6.2 [ X ], 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): Human tissues and cells  
5. Title, number of pages and langua ge(s) of the notified document: Draft Commission 
Directive amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (14 pages, in English) 
6. Description of content: This draft Commission Directive lays down the technical 
requirements for the coding of tissues and cells  by means of a European coding system in 
strict accordance with the requirements al ready set out in the Directive 2006/86/EC. The 
draft text provides definitions for each elemen t of the Single European Code (SEC), lays 
down the requirements for the application of  the SEC, the Members States obligations 
related to the application of the SEC, as well as the Commission's obligations. Some 
exclusions and exemptions from the applicatio n of the SEC are also proposed. A transition 
period is included to allow for the smooth implementation of the new coding requirements.  
7. Objective and rationale, including the nature of urgent problems where applicable: 
The measure aims to harmonise the coding requirements at EU level, thus reinforcing traceability of tissues and cells from donor to recipient and vice-versa. The measure is 
taken in compliance with Article 28 of Direct ive 2004/23/EC of the European Parliament 
and of the Council of 31 March 2004.  
It has to be underlined that human tissues and cells are not an ordinary "commercial" 
product: there is no conventional industrial production, voluntary and unpaid donation is 
strongly encouraged and according to the Charter of Fundamental Rights of the European 
Union commercialisation of the human body and its parts is prohibited. G/TBT/N/EU/229 
 
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  8. Relevant documents:  
Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 
setting standards of quality and safety for the donation, procurement, testing, processing, 
preservation, storage and distribution of human tissues and cells. 
http://eur-lex.europa.eu/legal-content/E N/TXT/PDF/?uri=CELEX:32004L0023&from=EN  
Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC 
of the European Parliament and of the Council as regards traceability requirements, 
notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells 
(Text with EEA relevance) 
http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32006L0086&qid=1404373105712&from=EN 
9. Proposed date of adoption:   December 2014 - January 2015 
Proposed date of entry into force:   20 days from publication in  the Official Journal of the 
EU   
10. Final date for comments: 60 days from notification 
11. Texts available from: Nati onal 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:  eu-tbt@ec.europa.eu  
The text is available on the EU-TBT Website : http://ec.europa.eu/enterprise/tbt/  
http://members.wto.org/crnattachments/2014/tbt/eec/14_3539_00_e.pdf