. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/EEC/94 
28 October 2005 
 (05-5001) 
Committee on Technical Barriers to Trade Original:   English 
  
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   EUROPEAN COMMUNITIES
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   European Commission 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:    
European Commission 
EC-TBT Enquiry Point 
Fax:  (+32) 2 299 80 43 E-mail:  ec-tbt@cec.eu.int 
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 applicable, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):   Human tissues and cells 
5. Title, number of pages and language(s) of the notified document:   Draft Commission 
Directive ../…/EC of […] implementing Directive 2004/23/EC of the European Parliament and of the Council as regards technical requi rements for the donation, procurement and 
testing of human tissues and cells. Ava ilable in all EC languages (20 pages) . 
6. Description of content:   The Commission Directive covers requirements for donation, 
procurement and testing of human tissues and cells and in particular it includes: 
− Requirements for the procurement of human tissues and cells; 
− Selection criteria for the donor of tissues and/or cells;  
− Laboratory tests required for donors;  
− Cell and/or tissue donation and procurement procedures and reception at the tissue 
establishment;  and 
− Requirements for direct distribution to the recipient of specific tissues and cells. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
The objective is to introduce technical require ments for each one of the steps in the human 
tissue and cell application process in the Europ ean Union so as to prevent the transmission 
of diseases by human tissues and cells for human applications and to ensure an equivalent level of quality and safety in all Member Stat es.  The measure is taken in compliance with 
Article 28 of Directive 2004/23/EC of the European Parliament and of the Council of 
31 March 2004 setting standards of quality a nd safety for the donation, procurement, 
testing, processing, preservation, storage a nd distribution of human tissues and cells. G/TBT/N/EEC/94 
Page 2  
 
 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://europa.eu.int/eur-lex/pri/en/oj/d at/2004/l_102/l_102200 40407en00480058.pdf 
9. Proposed date of adoption:   
Proposed date of entry into force:    January 2006 
20 days following publication in the Official 
Journal of the European Union 
10. Final date for comments:   60 days from publication 
11. Texts available from:  National enquiry point [    ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
European Commission 
EC-TBT Enquiry Point 
Fax:  (+32) 2 299 80 43 
E-mail:  ec-tbt@cec.eu.int