. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/EEC/153 
16 May 2007 
 (07-2002) 
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:   EUROPEAN COMMUNITIES
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   European Commission 
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:    
European Commission 
EC-TBT Enquiry Point Fax:  +(32) 2 299 8043  E-mail:  ec-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 [   ], 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):   Toothpastes containing 
fluoride 
5. Title, number of pages and language(s) of the notified document:   Draft Commission 
Directive amending Council Directive 76/768/ EEC, concerning cosmetic products, for the 
purposes of adapting Annex III thereto to technical progress (4 pages, available in English). 
6. Description of content:   Fluorine compounds are currently listed in and subject to 
restrictions and conditions la id down in Annex III, Part 1 of Directive 76/768/EEC.  The 
Scientific Committee on Consumer Products (SCCP ) is of the opinion that if the sole source 
of fluoride exposure is toothpaste containing fluoride between 1000-1500 ppm, there is only 
a minimal concern that children under the age of six will develop fluorosis, provided that 
such toothpaste is used as recommended.  Therefore, reference numbers 26 to 43, and 
reference numbers 47 and 56 of Annex III, Pa rt 1 should be amended accordingly by 
introducing a labelling requirement. 
7. Objective and rationale, including the natu re of urgent problems where applicable:  
Protection of human health 
8. Relevant documents:   Draft Commission Directive amending Council Directive 
76/768/EEC, concerning cosmetic  products, for the purposes of adapting Annex III thereto 
to technical progress; SCCP Opinion on the safety of fluorine compounds in oral hygiene products for children under the age of 6 years: 
http://ec.europa.eu/health/ph_ris k/committees/04_sccp/docs/sccp_o_024.pdf; G/TBT/N/EEC/153 
Page 2  
 
  Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the 
Member States relating to cosmetic products (text of Council Directive is under: http://europa.eu.int/comm/enterprise/co smetics/html/consolidated_dir.htm) 
9. Proposed date of adoption:   
 
Proposed date of entry into force:    Adoption and publication in the Official 
Journal of the EU: July 2007;  
On the twentieth day following the publication 
in the Official Journal of the EU;  
Transposition by EU Member States: 9 months 
after the entry into force of the Directive. 
10. Final date for comments:   60 days from date of notification 
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:   
European Commission 
EC-TBT Enquiry Point 
Fax: +(32) 2 299 8043 
E-mail: ec-tbt@ec.europa.eu 
The text is available on the EC-TBT We bsite: http://ec.europa.eu/enterprise/tbt/