. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/NOR/19 
15 September 2006 
 (06-4440) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Member to Agreement notifying:  NORWAY
 
If applicable, name of local government involved:  The Royal Ministry of Health and Care 
Services  
2. Agency responsible:  The Norwegian Food Safety Authority  
3. Products covered (provide tariff item number(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where applicable):   External healthcare products :  Substances or mixtures 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 health 
problems not due to disease.  
4. Regions or countries likely to be affected, to the extent relevant or practicable:  All 
trading partners  
5. Title, language and number of pages of the notified document:  Draft of new regulation 
of xx.xx.2006 concerning external healthcare produc ts (Available in English and Norwegian;  
Number of pages:  17 (Draft Regulatio n) + 1 (Appendix to Draft Regulation))  
6. Description of content:  The draft regulation encompasses all situations associated with 
developing, producing, importing, processing, distributing,  exporting and selling external 
healthcare products and health personnel's duty to report any si de effects when using such 
products.  
7. Objective and rationale: [   ] food safety,  [   ] animal health,  [   ] plant protection, 
[ X ] protect humans from animal/plant pest or disease, [   ] protect territory from other damage from pests   
The draft regulation is intended to supplemen t the new Norwegian Act of 21 December 2005 
No. 126 concerning cosmetics and body care product s etc.  Before the Act of 21 December 
2005 No. 126 came into force, the products in  question were regulated by Norwegian 
pharmaceutical law.  Under that set of rules, trade in such products was strictly regulated in Norway.  By contrast , pursuant to the Act of 21 Decem ber 2005 No. 126, these products are 
no longer regulated by the strict  provisions of Norweg ian pharmaceutical law,  but by the more 
lenient provisions of the new law on cosmetics and body care products.  However, there is still 
a need to regulate external he althcare products more closely th an ordinary cosmetic products. 
Consequently, the object of this draft regulation is to ensure a set of rules which on the one 
hand is more stringent than those applying to  ordinary cosmetics pr oducts, and on the other 
hand is less stringent than thos e applying to pharmaceuticals.  G/SPS/N/NOR/19 
Page 2  
 
  8. International standard, guideline or recommendation: 
[   ] Codex Alimentarius Commission,  [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention,  [ X ] None 
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:   
9. Relevant documents and language(s) in which these are available:   
1.  Council of Europe:  Cosmetic Pr oducts – Boarderline Situations (2000) 
2.  WHO:  The International Statistical Classi fication of Diseases a nd Related Problems (ICD) 
3.  OIE:  The International Statistical Classi fication of Diseases a nd Related Problems (ICD) 
4.  TBT-notification: G/TBT/N/NOR/3 ( notification issued 29 November 2004)   
5.  Contemporary SPS and TBT notifications of the three related Norwegian draft regulations 
concerning:  
− Products for Cutaneous Injection; 
− Tattooing Products;  and 
− Products for External Use for Care a nd Marking using Chemical Means of 
Animals. 
Available in English and Norwegian   
10. Proposed date of adoption:  1 January 2007 
11. Proposed date of entry into force:  1 January 2007 
12. Final date for comments:  15 November 2006 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [   ] National enquiry point, or address, fax number and E-mail address (if available) of other body:   
The Norwegian Food Safety Authority 
13. Texts available from:  [   ] National notification authority, [   ] National enquiry point, 
or address, fax number and E-mail address (if available) of 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