G/TBT/N/EU/317  
 
1 October 2015  
(15-5059)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member: EUROPEAN UNION 
If applicable, name of local government involved (Article 3.2 and 7.2):  
2. Agency responsible: European Commission 
Name and address (including telephon e 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 
EU-TBT Enquiry Point 
Fax: +(32) 2 299 80 43 E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools-databases/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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable): Chemical substances 
placed on the EU market 
5. Title, number of pages and language(s) of the notified document: Draft Commission 
Regulation amending Annexes VII and VIII to Regulation (EC) No 1907/2006 of the 
European Parliament and of the Council on the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH) as regards skin corrosion/irritation, serious eye damage/eye irritation, skin sensitisation and acute toxicity (4 pages + Annex 4 pages, in English) 
6. Description of content: Annexes VII to X of REACH provide the standard information 
requirements for substances that are subject to registration, depending on the 
production/import volume of a substance.  
Points 8.1, 8.2, 8.3 and 8.5 of Annexes VII and VIII define the REACH standard 
information requirements and adaptation possibili ties for the toxicological endpoints of skin 
irritation/corrosion, serious eye damage/eye irritation, skin sensitisation and acute toxicity, 
respectively. This draft Commission Regulation proposes the modification of the provisions of the REACH Annexes provided for these points  in order to reflect the scientific progress 
made in the development of alternative methods and approaches in the respective areas. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: According to Article 13(1) and 13(2) of REACH, information on the intrinsic 
properties of the substances, in particular fo r human toxicity, shall be generated, wherever 
possible, by means other than vertebrate test ing, through the use of alternative methods. 
These methods shall be regularly reviewed and improved with a view to reducing testing 
on vertebrate animals. The Commission shall make a proposal, if appropriate, to amend 
the REACH Annexes to implement the principle of replacement, reduction and refinement of animal testing. G/TBT/N/EU/317 
 
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  This draft Commission Regulation aims at removing in vivo test requirements for skin and 
eye irritation and acute toxicity at higher tonnage levels that are no longer scientifically justified. Therefore, in accordance with Article 13(2) of REACH it is proposed to amend the 
REACH Annexes as improved methods are available in order to replace, reduce or refine 
animal testing. 
For skin sensitisation, alternative methods are now becoming available, but are not yet 
widely used. Assessing skin sensitisation by alternative means is more complex, requiring 
the integrated assessment of several tests an d other information. Therefore, instead of 
replacing the in vivo test requirement, it is proposed to introduce a waiving possibility for 
in vivo tests if sufficient information can be generated by alternative methods. 
8. Relevant documents: Regulation (EC) No 1907/2006 of the European Parliament and of 
the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals 
(REACH Regulation) 
http://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1402583495337&uri=CELEX:32006R1907  
9. Proposed date of adoption: First quarter 2016 
Proposed date of entry into force: First quarter 2016 
10. Final date for comments: 60 days from notification 
11. Texts available from: National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
European Commission 
EU-TBT Enquiry Point 
Fax: + (32) 2 299 80 43 
E-mail: grow-eu-tbt@ec.europa.eu  
The text is available on the Website: http://ec.europa.eu/growth/tools-databases/tbt/  
https://members. wto.org/crnattachments/2015/TBT/EEC/15_3846_00_e.pdf  
https://members. wto.org/crnattachments/2015/TBT/EEC/15_3846_01_e.pdf