. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/EEC/403 
15 September 2011  
 (11-4440) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  EUROPEAN UNION  
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 
EU-TBT Enquiry Point Fax:  +(32) 2 299 80 43 E-mail:  mailto: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 applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Presence of  
dimethylfumarate (DMF) in articles 
5. Title, number of pages and language(s) of the notified document:  Draft Commission 
Regulation amending Annex XVII to Regulat ion (EC) No 1907/2006 of the European 
Parliament and of the Council on the Registrati on, Evaluation, Authoris ation and Restriction 
of Chemicals (REACH) (4  pages, in English). 
6. Description of content:  The draft Regulation proposes the prohibition of the use of DMF in 
articles or parts thereof, in c oncentrations greater than 0.1 mg/kg as well as the placing on the 
market of articles or parts thereof containing DM F in concentrations greater than 0.1 mg/kg. It 
makes permanent an existing temporary prohibi tion adopted under Directive 2001/95/EC on 
general product safety.  
7. Objective and rationale, including the nature of urgent problems where applicable:  The 
use of DMF as a biocide is not authorized in  the EU.  The objective of the draft Commission 
Regulation is to reduce the exposure for humans  to DMF contained in imported articles.  The 
draft Commission Regulation w ill make permanent the current prohibition imposed by 
Decision 2009/251/EC of 17 March 2009 requiring  Member States to ensure that products 
containing the biocide dimethylfumarate are not placed or made available on the market (notified to the WTO under references G/TBT/N/EEC/258, G/TB T/N/EEC/258/Add.1, 
G/TBT/N/EEC/258/Add.2, a nd G/TBT/N/EEC/258/Add.3).  G/TBT/N/EEC/403 
Page 2  
 
  8. Relevant documents:    
- Regulation (EC) No 1907/2006 of the Europe an Parliament and of the Council on the 
 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ 
 L 396, 30.12.2006, p.1) 
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=OJ :L:2006:396:0001:0849:EN:PDF  
- The compiled opinions of the Committ ees for Risk Assessment (RAC) and Socio-
 economic Analysis (SEAC): 
http://echa.europa.eu/doc/restrict ions/background_doc_seac_rac_dmfu.pdf  
- The background document to RAC and SEAC opinions on DMF: 
http://echa.europa.eu/doc/restrict ions/background_doc_seac_rac_dmfu.pdf   
9. Proposed date of adoption:   
Proposed date of entry into force:    March 2012 
March 2012 (As a ban on DMF exists since 
March 2009, no transition period has been deemed necessary.) 
10. Final date for comments:  60 days from date of notification. 
11. Text available from:  National enquiry point [  ], or address, telephone and fax numbers, 
e-mail and web-site addresses, if available of the other body:    
European Commission 
EU-TBT Enquiry Point Fax:  + (32) 2 299 80 43 E-mail:  mailto:eu-tbt@ec.europa.eu  
The text is available on the EU-TBT Website :  http://ec.europa.eu/enterprise/tbt/  
http://members.wto.org/crnatt achments/2011/tbt/EEC/11_2966_00_e.pdf