. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/EEC/87 
21 June 2005 
 (05-2625) 
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 blood and blood 
components 
5. Title, number of pages and language(s) of the notified document:   Draft Commission 
Directive ../…/EC of […] implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standa rds and specifications relating to a quality 
system for blood establishments (12 pages, in English also available in all EC languages ) 
6. Description of content:   The Commission Directive covers  
1. The standards and specifications related to a quality system that must be put in 
 place by blood establishments including: 
− General principles 
− Personnel and organisation 
− Premises 
− Equipment and materials 
− Documentation 
− Blood collection, testing and processing 
− Storage and distribution 
− Contract management 
− Non-conformance 
2. Self-inspection, a udits and improvements G/TBT/N/EEC/87 
Page 2  
 
 7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of human health. 
This directive will introduce technical requireme nts in the European Union so as to ensure 
an equivalent level of quality and safety in a ll Member States.  The measure is taken in 
compliance with Article 29 of Directive 2002/98/EC  of the European Parliament and of the 
Council of 27 January 2003 setting standards of quality and safety for the collection, testing, 
processing, storage and distribution of hu man blood and blood components and amending 
Directive 2001/83/EC 
8. Relevant documents:   Directive 2002/98/EC of the European Parliament and of the 
Council of 27 January 2003 setting standards of quality and safety for the collection, testing, 
processing, storage and distribution of hu man blood and blood components and amending 
Directive 2001/83/EC; 
http://europa.eu.int/eur-lex/pri/en/oj/d at/2003/l_033/l_033200 30208en00300040.pdf 
9. Proposed date of adoption:   
Proposed date of entry into force:    September 2005 
20 days following publication in the Official 
Journal of the European Union 
10. Final date for comments:   60 days from the date of notification 
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