. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/EEC/298 
8 October 2009  
 (09-4863) 
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, for the purpose of adaptation to technical progress, Annex III to Council 
Directive 76/768/EEC concerning cosmetic pr oducts (5 pages, in English).     
6. Description of content:  Presently, there are 29 oxidative hair dye substances which are 
provisionally allowed for use in  cosmetics until 31 December 2009 under the restrictions and 
conditions laid down in Part 2 of Annex III to Directive 76/768/EEC. The scientific data, 
required by the EU safety assess ment strategy for hair dyes, on the safety of reaction products 
formed by oxidative hair dye substances were evaluated by the Scientific Committee on 
Consumer Safety (SCCS). In January 2009, the SC CS concluded in its opinion that it is not in 
a position to finally assess the risk of reacti on products of oxidative hair dyes due to the 
incompleteness of the data submitted by industr y. The cosmetics industry responded to this 
opinion by stating that it envisages to provide  the missing data by September 2009 at the 
latest. Therefore, the definitive regulation of 29 oxidative hair dye substances listed in Part 2 
of Annex III, on the basis of risk assessment of their reaction products,  and its implementation 
into the laws of Member States will not ta ke place before the provisional deadline of 31 
December 2009. Consequently, their provision al use in cosmetics under the current 
restrictions and conditions laid down in Part 2 of Annex III should be extended. For two non-
oxidative hair dye substances HC Orange No . 2 and 2-hydroxyethylamino-5-nitroanisole, 
listed under reference numbers 26 and 29 in Part 2 of Annex I II, the SCCS gave its final 
opinions on their safety. The SCCS recommended maximum authorized concentrations in the 
finished cosmetic product of 1,0% for HC Orange No. 2 and of 0,2% for 2-G/TBT/N/EEC/298 
Page 2  
 
  hydroxyethylamino-5-nitroanisole.  
In view of the above, the European Commission intends: • To extend the provisional use of 29 oxi dative hair dye substances under the current 
restrictions and conditions laid down in Pa rt 2 of Annex III until 31 December 2010.   
• To regulate substances HC Or ange No. 2 and 2-hydroxyethylamino-5-nitroanisole in Part 1 
of Annex III, allowing their use in hair dyes up to the new maximum authorized 
concentrations. 
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 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1976L0768:20080424:EN:PDF)    
9. Proposed date of adoption:   
 
Proposed date of entry into force:    Adoption and publication in  the Official Journal 
of the EU: December 2009 
Entry into force: twentieth day 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 can be downloaded here: http://members.wto.org/crnatt achments/2009/tbt/eec/09_3472_00_e.pdf