EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2015) 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 methanol  
(Text with EEA relevance)   EN 2   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 methanol  
(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 concerning the Registration, Evaluation, Authorisation and 
Restriction of Ch emicals (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 16 January  2015, Poland  submitted to the European Chemicals Agency (‘the 
Agency’) a dossier2 pursuant to Article 69(4) of Regulation (EC) No 1907/2006  (‘the 
Annex XV dossier’), in order to initiate the restriction procedure set out in Articles 69 
to 73 of that Regulation. The Annex XV dossier indicated that exposure to methanol in 
windscreen washing  fluid  and denatured alcohol poses a risk to human healt h and 
proposed to prohibit the ir placing on the market. The Annex XV dossier demonstrated 
that action on a Union -wide basis is necessary.  
(2) The restriction proposed in the Annex XV dossier aims to reduc e the incidence of 
severe methanol poisoning following consumption by chronic alcoholics and 
sporadically by non -alcoholics of windscreen washing fluids or denatured alcohol used 
as a cheap substitute for consumable alcohol. The restriction is also expected to 
prevent methanol poisoning following accidental ingestion of winds creen w ashing 
fluids and denatured alcohol, including poisoning s in children.  The Annex XV dossier 
and the public consultation reported cases of poisoning caused by ingestion of 
windscreen  washing  fluids in seven  Member States and fatal cas es in at least two 
Member States.  
(3) On 4 December 2015 , the Agency's  Committee for Risk Assessment  ('RAC ') adopted 
its opinion con cluding  that exposure to  methanol  present in windscreen  washing  fluids 
and in denatured alcohol  in a concentration above 0.6% by weight presents  a risk of 
death, severe  ocular toxicity or other severe effects  of methanol poisoning . RAC 
further advised that the proposed restriction  is the most appropriate  Union -wide 
                                                 
1 OJ L 396, 30.12.2006, p 1.  
2  https://echa.europa.eu/documents/10162/78b0f856 -3751 -434b -b6bc -6d33cd630c85   EN 3   EN measure to address the risks identified , both in terms  of effectiveness and 
practicability.  
(4) On 11 March 2016, the Agency's  Committee for Socio -Economic Analysis  ('SEAC ') 
adopted its opinion on the  proposed  restriction . As regards  denatured  alcohol, the lack 
of socio -economic data in the Annex XV dossier and  from  the public consultation 
meant that SEAC could not evaluate the socio -economic impact of its inclusion in the 
proposed restriction . Regarding windscreen  washing  fluids, SEAC considered that  the 
proposed restriction is the most appropriate Union -wide m easure  to address the risks 
identified in terms of its socio -economic benefits and socio -economic costs.  Overall, 
SEAC considered that divergencies in national legislation across Member States  could 
distort the internal market.  
(5) The Agency's Forum for Excha nge of Information on Enforcement was consulted  
during the restrictions process  and its advice has  been  taken into account , notably to  
include in the  proposed  restriction  fluids used to defrost  winds creens . 
(6) On 28 April 2016 , the Agency submitted the opinions of  the RAC and the SEAC to 
the Commission3. Based on those opinions,  the Commission concluded that the 
presence  of methanol in winds creen  washing  fluids , windscreen  defrosters  and 
denatured alcohol  poses an unacceptable risk to human health  which needs to be 
addressed on a Union -wide basis .  
(7) Stakeholders should be allowed sufficient time to take appropriate measures  to comply 
with the proposed restriction , in particular to allow sales of stocks and to ensure 
adequate communication within th e supply  chain.  The application of the  restriction 
should therefore be deferred . 
(8) Regulation (EC) No 1907/2006 should therefore be amended accordingly.  
(9) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee established und er Article 133 of Regulation (EC) No 1907/2006,  
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 Union .  
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  
                                                 
3 https://echa.europa.eu/documents/10162/2b3f6422 -ab4d -4b85 -9642 -ebe225070858