. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/NOR/11 
15 September 2006 
 (06-4434) 
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:   NORWAY
 
If applicable, name of local government involved (Articles 3.2 and 7.2):    
The Royal Ministry of He alth and Care Services 
2. Agency responsible:   The Norwegian Food Safety Authority 
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):   External healthcare 
products: Substances or mi xtures of substances meant to come  into contact with  the surface of 
the body of humans or animals, teeth or mucous membranes in the mouth or nostrils solely or 
mainly to prevent, relieve or treat he alth problems not due to disease.   
Regions or countries likely to be affected: All trading partners . 
5. Title, number of pages and language(s) of the notified document:   Draft of new 
regulations of xx.xx.2006 concerning external heal thcare products (17 pages, in English Draft 
Regulations) + (1 Appendix to Draft Regulations). 
6. Description of content:   The draft Regulations encompass all situations associated with 
developing, producing, importing, processing, distributing,  exporting and selling external 
healthcare products and Norwegian health pers onnel’s duty to report any side effects when 
using such products. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health:  The draft Regulations are intend ed to supplement the Norwegian 
Act of 21 December 2005 No. 126 concerning cosmet ics and body care produ cts etc.  Before 
the Act of 21 December 2005 No. 126 came in to force, the products in question were 
regulated by Norwegian pharmaceutical law.  Under that set of rules, trade in such products was strictly regulated in Norw ay.  By contrast, pursuant to the Act of 21 December 2005 No. 
126, these products are no longer regulated by the strict provisions of Norwegian 
pharmaceutical law, but by the more lenient pr ovisions of the new law on cosmetics and body 
care products.  However, there is still a need to regulate ex ternal healthcare products more 
closely than ordinary cosmetic products.  Conseq uently, the object of thes e draft regulations is 
to ensure a set of rules which on the one ha nd is more stringent than those applying to 
ordinary cosmetics products, and on the other hand is less stringent than those applying to 
pharmaceuticals.   G/TBT/N/NOR/11 
Page 2  
 
  8. Relevant documents:    
A. Council of Europe: Cosmet ic Products – Boarderline Situations (2000) 
B. WHO: The International Statistical Classi fication of Diseases and Related Problems 
(ICD)  
C. OIE: The International Statistical Classi fication of Diseases and Related Problems 
(ICD)  
D. TBT-notification: G/TBT/N/NOR/3 
E. Contemporary TBT notifications of th e three related Norwegian regulations 
concerning:  
− Products for Cutaneous Injection  
− Tattooing Products 
− Products for Care and Marking of Animals  
 
9. Proposed date of adoption:   
Proposed date of entry into force:   }1 January 2007 
10. Final date for comments:   - 
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:   
The Norwegian Food Safety Authority 
Head Office P.O. Box 383 N – 2381 – Brumunddal Norway  
Fax: +47 23 21 68 01 
E-mail: postmottak@mattilsynet.no