G/TBT/N/EU/216  
 
18 June 2014  
(14-3553)  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:  eu-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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable): Chemical substances 
placed on the EU market in relatively high volumes 
5. Title, number of pages and langua ge(s) of the notified document: Draft Commission 
Regulation amending Annexes VIII, IX and X 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 the Extended One-Generation Reproductive Toxicity Study (9 pages, in English) 
6. Description of content: This draft Regulation proposes th e modification of Annexes VIII, 
IX and X in order to adapt the standard information requirements to a new test method which was developed to assess the reproductive toxicity of chemical substances. The 
amended standard information requirement implements the new test method – extended 
one-generation reproductive toxicity study (EOGRTS) – which will replace the two-generation reproductive toxicity study which is currently the standard information required 
in certain cases for REACH registration.  
7. Objective and rationale, including the nature of urgent problems where applicable: 
EOGRTS was adopted by the OECD in July 2011. The new test method is considered to 
offer a number of advantages compared to the two-generation reproductive toxicity study. 
It offers improved sensitivity and, by addres sing additional parameters, increases the level 
of information that can be obtained from the test. Furthermore, as breeding of the second 
generation is not part of the basic test design under the amended standard information 
requirements under REACH, overall, a significant reduction in the number of animals used is achieved.  G/TBT/N/EU/216 
 
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  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:   last quarter 2014 
Proposed date of entry into force:   last quarter 2014   
10. Final date for comments: 60 days from notification 
11. Texts available from: Nati onal enquiry point [ ] or address, telephone and fax 
numbers email and website addresses,  if available, of other body:  
European Commission 
EU-TBT Enquiry Point Fax:  + (32) 2 299 80 43 
E-mail:  eu-tbt@ec.europa.eu  
The text is available on the EU-TBT Website :  http://ec.europa.eu/enterprise/tbt/  
http://members.wto.org/crnattachments/2014/TBT/EEC/14_2744_00_e.pdf