EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2017) 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 octamethylcyclotetrasiloxane ('D4') and 
decamethylcyclo pentasiloxane ('D5')  
(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 octamethylcyclotetrasiloxane ('D4') and 
decamethylcyclopentasil oxane ('D5')  
(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 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 17 April 2015,  the United Kingdom  submitted to the Agency  a dossier pursuant to 
Article  69(4) of Regulation (EC) No 1907/2006 ('the Annex XV dossier2'), proposing 
to restrict octamethylcyclotetrasiloxane  (D4) and decamethylcyclopentasiloxane  (D5) 
in cosmetic  products that are washed off in normal conditions of use . The dossier 
demonstrated that action on a Union -wide basis is necessary to address the risks to the 
environment posed by the use of D4 and D5 when discharged into waste water . 
(2) On 2 2 April 2015 , the Member State Committee , referred to in Article  76(1)(e) of 
Regulation (EC) No  1907/ 2006 , at the request of the Executive Director of the 
European Chemicals Agency ( 'the Agency ') under Art icle 77(3) (c) of that Regulation , 
adopted an opinion that both D4 and D5 fulfil the criteria in Annex XIII to that 
Regulation for the identification of very persistent ( vP) and very bioaccumulative ( vB) 
substances . 
(3) On 10 March 2016 , the Agency's Risk Assessment Committee ('RAC')  adopted its 
opinion, concluding that D4 meets the criteria in Annex XIII to Regulation (EC) No 
1907/2006 for the identification of a persistent, bioaccumulative and toxic ('PBT') 
substance and a vPvB substance  and that D5 meets the criteria for the identification of 
a vPvB substance . RAC confirmed that th e hazard properties of D4 and D5  give rise to 
specific concerns for the environment when present in cosmetic products  that are used 
or disposed with water . It also concluded  that the proposed restriction is a targeted and 
appropriate U nion wide measure to minimise emissions caused by washed off  
products . 
                                                 
1 OJ L 396, 30.12.2006, p  1. 
2 https://echa.europa.eu/documents/10162/9a53a4d9 -a641 -4b7b -ad58 -8fec6cf26229   
EN 3   EN (4) On 9 June 2016, the Agency's Socio -Economic Assessment Committee ('SEAC') 
adopted its opinion, indicating that the proposed restriction is the most appropriate 
Union -wide measure to reduce the discharge  of D4 and D5 to waste  water  in terms of  
its socio -economic benefits and its socio -economic costs.  
(5) SEAC recommended a  twenty four month deferral of application of the restriction , in 
line with the minimum period of deferral  proposed in the Annex XV dossier , to allow 
stakeholders to take the necessary compliance measures.  
(6) The Agency ’s Forum for Exchange of Information on Enforcement , referred to in 
Article  76(1)(f)  of Regulation (EC) No  1907/2006 , was consulted during the 
restriction process and its recommendations have been  taken into account.  
(7) On 10 August 2016 , the Agency submitted to the Commission the opinions of RAC 
and SEAC3. 
(8) A risk to the environment arises from the presence  of D4 and D5 in certain cosmetic 
products that  are washed off with water  after application , because of their hazard 
properties as a PBT and a vPvB substance in the case of  D4 and a vPvB substance in 
the case of D5. The Commission considers that those risks should be addre ssed on a 
Union wide basis . The concentration limit of 0.1% set by this restriction effectively 
ensures that all intentional use of D4 and D5 will cease  since those substances must be 
present in wash -off cosmetic products in a much higher concentration to perform their 
intended function.  
(9) The proposed restriction concerns cosmetic products as defined in Article 2(1)(a) of 
Regulation (EC) No 1223/2009  of the European Parliament and of the Council4. In 
cosmetic products that are intended to stay in prolonged c ontact with the skin, the hair 
or the mucous membranes , D4 and D5  evaporate over time after application and any 
residue is washed off in the course of normal ablutions. The Annex XV dossier did not 
cover those products , considering that they did not repres ent the major source of risk 
to the environment from D4 and D5 , and consequently the risk which they may 
present to the environment has not yet been assessed by RAC.  Therefore, t he 
restriction should apply only to wash -off cosmetic products that, under nor mal 
condition of use, are removed with water shortly after application because in these 
circumstances D4 and D5 are emitted to the aquatic environment before evaporation.  
(10)  Stakeholders should be allowed sufficient time to take appropriate compliance 
measur es to comply with the proposed restriction . The new restriction should therefore 
only apply from a later date  
(11) Regulation (EC) No  1907/2006 should therefore be amended accordingly.  
(12) The measures provided for in this Regulation are in accordance with the opin ion of the 
Comm ittee established under 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.  
                                                 
3 https://echa.europa.eu/documents/10162/7209f47e -58a0 -4fa7-9890 -11366f5aa4e9  
4 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 
on cosmetic products (OJ L315, 26.11.2013, p. 341).   
EN 4   EN 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