 
  WORLD TRADE  
ORGANIZATION  G/TBT/N/JPN/117 
17 February 2004 
 
 (04-0653) 
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:   JAPAN
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Ministry of Health, Labour and Welfare(MHLW) 
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 [ 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):   drugs, quasi-drugs, 
cosmetics and medical devices (HS:30) 
5. Title, number of pages and language(s) of the notified document:   Partial revision of  the 
Minimum Requirements for Biological Ingredients.(1 page, available in English) 
6. Description of content:   To delete “Canada”, where B SE-infected case was observed, from 
the list of origin countries of the ruminant s that can be used as source materials for 
pharmaceuticals, etc., in the Standard for Ruminant-Derived Ingredients , the Standard for 
Biological Ingredients .  To add “New Caledonia” and “Vanuatu” to the same list. Also to 
add the provision on ruminant-derived ingredients for cosmetics to  the Standard for 
Ruminant-Derived Ingredients. The current provision on ruminant-derived ingredients in 
the Cosmetics Standard  will be deleted from the Cosmetics Standard  concomitantly with 
the above-mentioned revision of the Standard for Ruminant-Derived Ingredients . 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
To ensure the safety of the ruminant-derived  pharmaceuticals, quasi-drugs, medical devices 
and cosmetics by eliminating the source materials from the BSE-tainted countries in 
principle. 
8. Relevant documents:   The relevant law is the Pharmaceutical Affairs Law . 
9. Proposed date of adoption:   
Proposed date of entry into force:   }In March 2004 
10. Final date for comments:   15 March 2004 
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:        
 