  
  
G/TBT/N/EU/749  
24 September 2020  
(20-6487) 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/tbt/e n/ 
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [X], 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):  N,N-
dimethylformamide; Products of the chemical industry (ICS 71.100)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the 
European Parliament and of th e Council concerning the Registration, Evaluation, 
Authorisation and Restriction of Chemicals (REACH) as regards N,N -dimethylformamide 
(4 page(s), in English; 2 page(s), in English)  
6. Description of content:  This draft Regulation relates to a new entry o f Annex XVII to 
Regulation (EC) No 1907/2006.  
The draft Commission Regulation proposes a restriction for placing N,N-
dimethylformamide (DMF) on the market in concentrations higher than 0.3%, unless the 
registration dossiers and the safety data sheet are up dated with the new Derived No -
Effect Level (DNEL) values, and manufacturers and downstream users ensure the 
protection of workers by keeping their exposure below those values.  
Application of the restriction is deferred for 2 years for all industrial sectors.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The occupational exposure to N,N-dimethylformamide above the following 
Derived No -Effect Levels (DNELs): 6 mg/m3 for exposure by inhalation and 1,1 
mg/kg/day for dermal exposure, poses a risk to human health due to its reprotoxic and 
hepatotoxic properties. The aim of the restriction is to ensure that the risks resulting from 
inhalation and skin exposure to DMF are adequately controlled. The transition al period (2 
years) before the application of the proposed restriction will allow stakeholders sufficient 
time to comply with the proposed restriction and to ensure adequate communication 
throughout the supply chain; Protection of human health or safety  G/TBT/N/EU/749  
 
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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=1423064258789&uri=CELEX:32006R1907  
• https://echa.europa.eu/es/registry -of-restriction -intentions/ -
/dislist/details/0b0236e18213ec9e   
9. Proposed date of adoption:  First quarter of 2 021 
Proposed date of entry into force:  20 days from publication in the Official Journal of 
the EU. Application of the restriction would be deferred for 48 months after entry into 
force.  
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_ 5701_00_e.pdf  
https://members.wto.org/crnattachments/2020/TBT/EEC/20_5701_01_e.pdf  
 