G/TBT/N/EU/522  
 
13 October 2017  
(17-5517) 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 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/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): Chemical 
substances in nanoform/nanomaterials  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Regulation amending 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 Annexes I, III, VI, VII, VIII, IX, X, XI, and XI I to address 
nanoforms of substances (and its accompanying annex) (6 + 26 pages, in English)   
6. Description of content: Nanoforms are chemical substances that fulfil the Commission 
Recommendation 2011/696/EU on the definition of nanomaterial.  
The purpose  of this draft Regulation is to clarify registration duties and obligations for 
nanoforms of substances under REACH by amending its technical Annexes: Annex I, with 
general provisions for assessing substances and preparing  chemical safety reports; 
Annex  III and Annexes VI to XI, with the standard information requirements for 
substances to be registered in different quantities placed on the market in the EU, 
requirements on substance identification and general rules for adaptation of standard 
testing regime;  and Annex XII, containing provisions for downstream users to assess 
substances and prepare chemical safety reports.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health and the environment, ens uring the proper 
functioning of the EU internal market. The REACH Regulation lays down specific 
registration duties and obligations on manufacturers, importers and downstream users to 
generate data on substances they manufacture, import or use to assess th e risks related to 
these substances and to develop and recommend appropriate risk management measures.  
Nanoforms of substances may have specific toxicological profiles and exposure patterns, 
and may require specific risk assessment and adequate sets of ri sk management G/TBT/N/EU/522  
 
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  measures. Clarifications to requirements for the registration of nanoforms of substances 
and related downstream user obligations should be included in the Annexes I, III and VI -
XII to the REACH Regulation to ensure that the risk assessments c onducted are 
appropriate.  
8. Relevant documents:  Regulation (EC) No 1907/2006 of the European Parliament and of 
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 353, 
31.12.2008, p. 1.)  
http://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:02006R1907 -20170102  
Commission Recommendation 2011/696/EU of 18 Octobe r 2011 on the definition of 
nanomaterial (OJ L 275, 20.10.2011, p. 38 –40) 
http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1486928403347&uri=CELEX:32011 H0696   
9. Proposed date of adoption:  End of March 2018  
Proposed date of entry into force:  20 days from publication in the Official Journal of the 
EU (about a month after adoption). Mandatory application: 1  January 2020.  
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/2017/TBT/EEC/17_4642_00_e.pdf  
https://members.wto.org/crnattachments/2017/TBT/EEC/17_4642_01_e.pdf