WORLD TRADE
ORGANIZATIONG/TBT/N/NLD/6
15 February 2001
(01-0758)
Committee on Technical Barriers to Trade Original:  English
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   THE NETHERLANDS
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Ministry of Health, Welfare and Sport
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:           
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 applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Human body tissue,
whether processed or not, and products manufactured on the basis thereof
5. Title, number of pages and language(s) of the notified document:   Bill on the safety and
quality of body tissue
6. Description of content:   The bill relates to body tissue, in other words tissue of human
origin that is intended for use, in either processed or unprocessed form, in medical
treatment.  In the first place, the bill prov ides for a duty for body tissue, after it has
become available, to be offered to an organ bank recognised by the minister (apart
from exceptions;  Article 4).  In principle, the import of body tissue is reserved forrecognised organ banks (Article 7).  In the second place the bill makes it possible to set
requirements for the removal, storage, trea tment, transport, transfer and import of body
tissue, both by organ centres and organ banks as well as by third parties (Article 8,
paragraphs 1 and 2).  In the third place the bill prohibits the supply of processed body tissue
without approval from an establishment designated by the Minister (Article 6).
7. Objective and rationale, including the na ture of urgent problems where applicable:
The bill intends to guarantee the safety and quality of body tissue in order to protect the
recipient of the tissue, that is to say the pe rson for whom the tissue is used in medical
treatment, against the transmission of infectious diseases and against bad quality products.
In Article 6, paragraph 2, the bill contains a mutual recognition clause for the inspection of
processed body tissue.  Imported unprocessed body tissue must be assessed at all times by
an organ bank as regards the risks to public health.
8. Relevant documents:   -
9. Proposed date of adoption:  31 December 2001
Proposed date of entry into force:  1 January 2002
10. Final date for comments:   23 April 2001
11. Texts available from:  National enquiry point [ X] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body: