G/TBT/N/EU/753  
21 October 2020  
(20-7273) 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 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 Comm ission,  
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/tb t/en/  
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):  
Substances  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Regulation amending Annexes VII to XI to Regulation (EC) No 1907/2006 of 
the European Parliament and of the Council concerning the Registration, Evaluation, 
Authorisation and  Restriction of Chemicals (REACH) (Text with EEA relevance) (15 
page(s), in English)  
6. Description of content:  The draft Commission Regulation provides clarifications of 
certain provisions in the Annexes to Regulation (EC) No 1907/2006 on the obligations  for 
registrants under Title II and on the role and responsibilities of the Agency under Title VI 
of that Regulation. The Commission and the European Chemicals Agency had concluded 
in their Joint Evaluation Action Plan of June 2019  that certain provisions in the Annexes 
of that Regulation would benefit from some re -wording so that they can be applied more 
consis tently.  
The changes cover the introductory texts of the Annexes to provide more information as 
to how to perform animal testing with respect to dose -setting for human health and 
environmental purposes. This should ensure that the information generated is adequate 
for hazard identification and risk assessment. A number of provisions on toxicological and 
ecotoxicological information are modified with a view to clarifying the obligations for 
registrants as well as waiving options and the responsibilities of t he Agency. In addition, 
certain provisions on information on the physicochemical properties of substances have  
been reworded to be more precise. Lastly, the general rules for adaptation of the standard 
testing regime have been modified in order to update t hem and to avoid the existing 
ambiguity of certain provisions.  G/TBT/N/EU/753  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Protection of the environment ; 
Ensuring the proper functioning of the EU internal market.  
8. Relevant documents:  Regulation (EC) No 1907/2006 of the European Parliament and 
the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation 
and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, 
amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and 
Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and 
Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 
30.12.2006, p.1)  
https://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1603118988074&uri=CELEX:32006R1907  
9. Proposed date of adoption:  4th Quarter 2020  
Proposed date of entry into force:  20 days from publication in the Official Journal of 
the EU (about a month after adoption).  
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 EU -TBT Website : http://ec.europa.eu/growth/tools -
databases/tbt/en/  
 
https: //members.wto.org/crnattachments/2020/TBT/EEC/20_6312_00_e.pdf  
https://members.wto.org/crnattachments/2020/TBT/EEC/20_6312_01_e.pdf