G/TBT/N/EU/601  
 
3 October 2018  
(18-6089) 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 [ 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): 
(3,3,4,4,5,5,6,6,7,7,8,8,8 -tridecafluorooctyl) silanetriol and any of its mono -, di-or tri-O-
(alkyl) derivatives with organic solvents in spra y products in a concentration, individually 
or in any combination, equal to or greater than 2 ppb by weight of the mixtures.  
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 the Council concerning the Registration, Evaluation, 
Authorisation and Restriction of Chemicals (REACH) as regards (3,3,4,4,5,5,6,6,7,7,8,8,8 -
tridecafluorooctyl) silanetriol and TDFAs (4 pages + Annex 2 p ages, in English)    
6. Description of content: This draft Regulation relates to a new entry of Annex XVII to 
Regulation (EC) No 1907/2006.  
It would restrict the placing on the market for the general public of 
(3,3,4,4,5,5,6,6,7,7,8,8,8 -tridecafluorooctyl)  silanetriol and any of its mono -, di-or tri-O-
(alkyl) derivatives (TDFAs) with organic solvents in a concentration, individually or in any 
combination, equal to or greater than 2 ppb by weight of the mixtures.  
Application of the restriction is deferred fo r 18 months to allow stakeholders sufficient time 
to adapt and achieve compliance.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: The exposure to (3,3,4,4,5,5,6,6,7,7,8,8,8 -tridecafluorooctyl) silanetriol  and 
any of its mono -, di-or tri -O-(alkyl) derivatives (TDFAs) with organic solvents in a 
concentration, individually or in any combination, equal to or greater than 2 ppb by weight 
of the mixtures poses a risk to human health, in particular a risk of seve re lung injury.  
The aim of the restriction is to prevent the occurring of the serious lung injury when used 
by the general public for spraying / impregnating applications.  
The 18 months of transitional period before the application of the proposed restrict ion will 
allow stakeholders sufficient time to comply with the proposed restriction and to ensure 
adequate communication within the supply chain.     G/TBT/N/EU/601  
 
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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  
• The opinions of the Committees for Risk Assessment (RAC) and Socio -economic 
Analysis (SEAC):  https://echa.europa.eu/documents/10162/574a629a -deac-cce0-
ced4-085cc8de4a48  
• Further background information is available at https://echa.europa.eu/previous -
consultations -on-restriction -proposals/ -/substance -rev/13918/term  
9. Proposed date of adoption: Second quarter of 2019.  
Proposed date of entry into force: 20 days from publication in the Official Journal of the 
EU (the restriction will begin to apply 18 months after the date of 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/2018/TBT/EEC/18_5164_00_e.pdf  
https://members.wto.org/crnattachments/2018/TBT/EEC/18_5164_01_e.pdf