EN   EN  
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2018) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
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) silanetr iol and TDFAs  
 
(Text with EEA relevance)  
 EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
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) silanetr iol and TDFAs  
 
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council of 18 December 2006 concern ing 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/EC1, and in particular Article 
68 (1) thereof,  
Whereas:  
(1) On 20 April 2016, the Kingdom of Denmark  submitted to the European Chemicals 
Agency (‘the Agency’) a dossier pursuant to Article 69(4) of Regulation (EC) No 
1907/2006, in order to initiate the restrict ions proce ss as set out in Articles 69 to 73 of 
that Regulation  (the ‘Annex XV dossier’) . The A nnex XV dossier indicated that 
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 (those derivatives are referred to as TDFAs) 
combined with organic solvents in spray products cause s serious acute lung injury  and  
therefore poses a risk  to human health . Accordingly, it  was proposed to prohibit the 
placing on the market  of those mixtures in spray products for supply to the general 
public . Denmark concluded that t he Annex  XV dossier demonstrated  that action on a 
Union -wide basis is necessary.  
(2) Denmark proposed a concentration limit of 2 ppb  by weight  for the presence of 
(3,3,4,4,5,5,6,6,7,7,8,8,8 -tridecafluorooctyl) silanetriol and any of the TDFAs in 
mixtures  containing organic solvents  as such concentration limit corresponds to a limit 
of detection .  
(3) On 10 March 2017,  the Agency's Committee for Risk Assessment (RAC ) adopted an 
opinion, con cluding  that the risks to the general public  arising  from the use of proofing 
or impregnating aerosol sprays  (the “spray products”)  containing  
(3,3,4,4,5,5,6,6,7,7,8,8,8 -tridecafluorooctyl) silanetriol  or TDFAs and organic solvents 
are not adequately controlled  and that the proposed restriction is  the appropriate  
measure to  reduce the risk s. Moreover, RAC considered that  the mixture of TDFA 
                                                 
1 OJ L 396, 30.12.2006, p 1.  EN 2  EN and/or (3,3,4,4,5,5,6,6,7,7,8,8,8 -tridecafluorooctyl) silanetriol with organic solvents 
should be labelled in a way that   ensure s that professional  users  of those products are 
aware of th e specific hazard associated with the use of th ose mixtures.  
(4) On 15 June 2017, the Agency’s Committee for Socio -economic Analysis (SEAC ) 
adopted its opinion, indicating that the proposed restriction, subject to modifications 
proposed by  RAC and SEAC, is the most appropriate Union -wide measure to address 
the risks  associated with the exposure to spray products containing mixtures of 
(3,3,4,4,5,5,6,6,7,7,8,8,8 -tridecafluorooctyl) silanetriol and TDFAs  with organic 
solvents , in terms of its socio -economic benefits and socio -economic costs. Taking 
into account  the uncertainties with regard to the presence of the spray products  
concerned  on the market  for supply to the general public , the effectiveness of the 
proposed measure , as well as the probable  low costs  of the proposal, SEAC concluded 
that the proposed restriction is not disproportionate.  
(5) SEAC concurred with Denmark  that a deferral of 18 months of the application of the 
restriction seems sufficient in order to allow stakeholders sufficient time to take 
appropriate measures to comply with the proposed restriction .  
(6) The Forum for Exchange of Information on Enforcement  was consulted during the 
restriction process in accordance with Article 77(4)(h) of Regulation (EC) No 
1907/2006  and its recommendations were  taken into account .  
(7) On 29 August 2017,  the Agency submitted to the Commission the opinions of RAC 
and SEAC2 based on which  the Commission concluded that placing on the market for 
supply to the general public  of spray products con taining (3,3,4,4,5,5,6,6,7,7,8,8,8 -
tridecafluorooctyl) silanetriol and/or TDFAs combined with organic solvents  poses an 
unacceptable risk to human health, that  needs to be addressed on a Union -wide basis .  
(8) Taking into account the Annex XV dossier  and the opinions of RAC and SEAC , 
including on the availability of alternatives, the Commission considers that the 
proposed restriction , as amended,  would address the identified concern  without 
imposing a significant burden on industry, supply chain or consume rs. Thus, the 
Commission conclude s that the restriction proposed by Denmark , amended as 
proposed by RAC and SEAC , is an appropriate Union -wide measure to address the  
risk to the general public  from spray products containing  a mixture of 
(3,3,4,4,5,5,6,6,7, 7,8,8,8 -tridecafluorooctyl) silanetriol and TDFAs with organic 
solvents.  
(9) Placing on the market for supply to the general public of spray products containing 
(3,3,4,4,5,5,6,6,7,7,8,8,8 -tridecafluorooctyl) silanetriol  and/or TDFAs combined with 
organic solvents includes making them available to the general public.  
(10) Stakeholders should be allowed sufficient time to take appropriate measures to comply 
with the proposed restriction. The application of the new restriction should therefore 
be deferred . 
(11) Regulat ion (EC) No 1907/2006 should therefore be amended accordingly . 
(12) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee established under Article 133 of Regulation (EC) No 1907/2006,  
                                                 
2 https://echa.europa.eu/previous -consultations -on-restriction -proposals/ -/substance -rev/13918/term   EN 3  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to 
this Regulation . 
Article 2 
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Uni on. 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker