. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/EEC/243 
22 January 2009  
 (09-0293) 
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 governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  European Commission 
Name and address (including telephone and fax numbers, email and website 
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@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):  Hair dye products.        
5. Title, number of pages and language(s) of the notified document:  Draft Commission 
Directive amending Council Directive 76/768/EE C, concerning cosmetic products, for the 
purpose of adapting Annex III thereto to technical progress (9 pages, in English). 
6. Description of content:  The Scientific Committee on Consumer Products (SCCP) 
recommended an overall safety assessment stra tegy for hair dye s ubstances including the 
requirements for testing substa nces used in hair dye pr oducts for their potential 
genotoxicity/mutagenicity.  
Following the opinions of the SCCP, the Commis sion, together with Member States and 
stakeholders, agreed on an overall strategy to regulate substances used in hair dye products, 
according to which the industry was required to  submit files containing the scientific data on 
hair dye substances to be evaluated by the SCCP.  
Substances for which updated safe ty files were submitted are currently being evaluated by the 
SCCP. For 17 hair dye substances final opin ions have already been given by the SCCP. 
Therefore, definitive regulation of these hair dy e substances, on the basis of such evaluations, 
can take place.  
Substances p-Phenylenediamine (PPD) and toluene-2,5-diamine (PTD) are currently 
regulated under entries 8 and 9 in part 1 of Annex III to Council Directive 76/768/EEC. The 
SCCP classified these substances as extreme se nsitizers contributing to a great extent to the G/TBT/N/EEC/243 
Page 2  
 
  incidence of skin allergies among consumers to hair dye products. The risk assessment of the 
submitted additional data on PPD and PTD, and final decisions made by the SCCP on the 
safety of these substances might still re quire a considerable amount of time. As a 
precautionary measure to reduce the risk of al lergies to hair dye pr oducts among consumers, 
the maximum authorized concentrations of PPD and PTD should be immediately decreased to 
the levels for which the industry submitted the safety files.  
In view of the above, the European Commission intends: • To create 17 new entries in Annex III, part 1 (“List of substances which cosmetic products 
must not contain except subject to the restrict ions and conditions laid down”) to Cosmetics 
Directive. 
To decrease the maximum authorized concentrations of PPD and PTD to the levels for which 
the industry submitted the safety files. Acco rding to this proposal, the maximum allowed 
concentrations for PPD and PTD, set out in Annex III, part 1 to Cosmetics Directive, in the 
hair dye formulations applied to hair will be 2% and 4%. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health.  
8. Relevant documents:   Council Directive 76/768/EEC of 27 July 1976 on the approximation 
of the laws of the Member States relating to cosmetic products(text: http://europa.eu.int/comm /enterprise/cosmetics/ht ml/consolidated_dir.htm
)   
9. Proposed date of adoption:   
 
Proposed date of entry into force:    Adoption and publication in  the Official Journal 
of the EU: April 2009 
Entry into force: 20 days following the 
publication in the Official Journal of the EU 
10. Final date for comments:  60 days from date of notification. 
11. Text available from: National enquiry point [  ], or addre ss, 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@ec.europa.eu 
The text is available on the EC-TBT Website:  http://ec.europa.eu/enterprise/tbt/ 
  
And: here