G/TBT/N/EU/230  
 
5 August 2014  
(14-4567)  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 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells  (16 pages, in 
English). 
6. Description of content: The draft text lays down the procedures for the authorisation and 
inspection of importing tissue establishments by EU Member States' tissues and cells 
competent authorities. Furthermore, it lays down the procedures to be followed by importing tissue establishments when applying for authorisations to import, in their relations with third country suppliers and ultimately when verifying the quality and safety 
of the tissues and cells they wish to import. The procedures closely mirror the quality and 
safety framework put in place within the EU.  
7. Objective and rationale, including the nature of urgent problems where applicable:  
The measure aims to harmonise the import 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/230 
 
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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  
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_3540_00_e.pdf