. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/EEC/107 
9 May 2006 
 (06-2228) 
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 80 43 
E-mail:  ec-tbt@cec.eu.int 
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):   Cosmetics 
(hair dye products) 
5. Title, number of pages and language(s) of the notified document:   Commission 
Directive amending Council Directive 76/768/ EEC, concerning cosmetic products, for the 
purpose of adapting Annex II and III thereto to technical progress (5 pages; in English) 
6. Description of content:   In 2001, a scientific study by Mr Gago-Dominguez on the “Use 
of permanent hair dyes and bladder cancer risk ” was published.  In its opinion of 12 June 
2001 on the “Use of Permanent Hair Dyes an d Bladder Cancer Risk”, the Scientific 
Committee on Cosmetic Products and Non- Food Products intended for Consumers 
(SCCNFP) evaluated the Gago-Dominguez-study a nd concluded that the potential risks are 
of concern (SCCNFP/0484/01).  It recommended that the Commission takes further steps to 
control the use of hair dye chemicals since the potential risk of using this category of 
substances give cause for concern. 
Following the opinions of the SCCNFP, the Co mmission together with member States and 
stakeholders agreed on an overall strategy to  regulate hair dyes within Council Directive 
76/768/EEC.  According to this strategy, the industry was required to submit safety files on 
hair dyes to be evaluated by the SCCNFP acco rding to the most recent requirements. The 
proposed Directive deals with two issues:  
1. Ban on 22 substances used as hair dy es for which no updated safety files were 
submitted. 
 Since existing toxicological data fo r these substances do not meet current 
 requirements for safety evaluation, they are not considered safe for human health. G/TBT/N/EEC/107 
Page 2  
 
   Based on a public consultation, there are no indications that these 22 substances are 
 currently used in hair dye products. 
2. Extension of provisional period until 31. 12.2007 during which certain hair dye 
substances are allowed. 
 The submission of about 110 dossiers by industry creates a large workload for the 
 SCCNFP which requires an extension of the deadline for substances provisionally 
 allowed in Part 2 of Annex III to Directive 76/768/EEC.   
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health. 
8. Relevant documents:   Commission Directive amending Council Directive 76/768/EEC, 
concerning cosmetic products, for the purposes of adapting Annex II and III thereto to 
technical progress; Council Directive 76/768/EEC of 27 July 1976 on the approximation of 
the laws of the Member States relating to cosm etic 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:  June 2006; 
Twentieth day following the publication in the 
Official Journal of the EU; Transposition by EU Member States:  by 1 September 2006 
10. Final date for comments:   30 days from circulation (a shortened period for comments is 
required in order to ensure that the provisi onal period during which hair dye substances 
from Part 2 of Annex III to Directive 76/768/EEC are allowed is extended before its expiry 
on 31.8.2006) 
The members States need a reasonable period to  transpose the directive into their legal 
system before 31.8.2006.  
From 1 December 2006 at the latest hair dye products which fail to comply with this 
Directive must not be placed on the market by Community manufacturers or by importers established within the Community, nor sold or dis posed of to the final consumer in order to 
ensure protection of human health. 
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 80 43 E-mail:   ec-tbt@cec.eu.int