EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2023) 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), 
decamethylcyclopenta siloxane (D5) and dodecamethylcyclohexasiloxane (D6)  
(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 octamethylcyclotetrasiloxane (D4), 
decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6)  
(Text with EEA relevance)  
THE EUROPEAN COMMIS SION,  
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 
Restricti on 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 10 January 2018 , the Commission adopted Commission Regulation 2018/352 
restricting  the placing on the market  of octamethylcyclotetrasiloxane (‘ D4’) and 
decamethylcyclopent asiloxane  (‘D5’) in wash -off cosmetic products. Th is restriction 
was inserted as entry 70 of Annex XVII to Regulation (EC) No 1907/2006 . 
(2) On 13 June 2018, D4, D5 and dodecamethylcyclohexasiloxane  (‘D6’) were identified 
by the Member State  Committee (‘ MSC ’) of the European Chemicals Agency (‘the 
Agency’)  as substances of very high concern ( ‘SVHC ’) with very persistent and very 
bioaccumulative (‘ vPvB ’) properties. D4 was identified as having persistent, 
bioaccumulative and toxic (‘ PBT’) properties.  D5 and  D6 were also identified as 
having PBT properties when they contain  0,1% or more  by weight  of D4. 
(3) When  the Agency's Risk Assessment Committee (‘RAC’) assessed the proposal of a 
restriction to the placing on the market of D4 and D5 that was ultimately adopted in 
Regulation 2018/35 , it did not exclude a potential risk from their use in leave -on 
cosmetic products.  For this reason, o n 15 December 2016 , the Commission requested3 
the Agency to prepare a dossier pursuant to  Article 69(1 ) of Regulat ion (EC) No 
1907/2006  (the ‘Annex XV dossier’) , with a view to a potential restriction of D4 and 
                                                 
1 OJ L 396, 30.12.2006, p. 1.  
2 Commission Regulation (EU) 2018 /35 of 10 January 2018 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 decamethylcyclopentasiloxane (‘D5’)  (OJ L 6, 11.1.2018, p. 45 ). 
3 https://echa.europa.eu/documents/10162/13641/echa_commis sion_request_en.pdf/a0bdbb25 -9641 -
9df1-9511 -4208cac224ce    
EN 2  EN D5 in leave -on cosmetic  products and other consumer and professional product s. On 5 
February 2018, the Commission requested4 the Agency to include D6 in the An nex 
XV dossier.  
(4) On 20 March 2019 , the Agency submitted the Annex XV dossi er5, which  
demonstrated that action on a Union -wide basis is necessary to address the risks to the 
environme nt posed by the use of D4, D5 and D6  when discharged into environmental 
compartments . 
(5) On 28 November 2019 , RAC adopted its opinion6, confirming th at the hazard 
properties of D4 , D5 and D6  give rise to specific concerns  for the environment when 
present in consumer  and professional  products that end up released  into both the 
aquatic and the atmospheric compartments . 
(6) RAC concluded that total releases of D4, D5 and D6 into the environment should be 
used as a proxy for risk. RAC also concluded that consumer and professional uses of 
leave -on cosmetic  product s and other consumer and professional products containing 
D4, D5 and D6 result in releases to the environment, with the wide -dispersive uses in 
cosmetic products  constituting the main source of releases . RAC agreed with the 
Agency’s assessment in the Annex XV dossier  that the risk is not adequately 
controlled and that emissions  of these vPvB and PBT substances are not minimised 
through their life  cycle , as required  in paragraph 6.5 of Annex I to Regulation (EC) No 
1907/2006 . 
(7) RAC  also concluded that the propo sed restriction is targeted and  the most appropriate 
Union -wide measure to minimise the emissions caused by leave -on cosmetic products 
and other consumer  and professional products  and to address the identified risk in 
terms of its effectiveness in  reducing  that risk , its practicality, and the manner in which 
it can be monitored.   
(8) On 12 March 2020, the Agency’s S ocio-Economic Assessment Committee (‘SEAC’) 
adopted its opinion7, indicating that the proposed restriction , as modified by  RAC and 
SEAC,  is the most appropriate Union -wide measure to reduce the emissions of D4, D5 
and D6 to the environment in terms of its socioeconomic benefits and costs.  
(9) SEAC concurred with the conclusions in the Annex XV dossier for a general deferral 
of two years of the  application of the restriction . 
(10) SEAC also concurred with longer deferrals for a number of specific uses.  Based on the 
time required for substitution, SEAC agreed with  a deferral of five years for leave -on 
cosmetic products and medical devices. As likely a lternative substances or 
technologies would not result in an overall reduction of the risk, SEAC also agreed 
with a deferral of the restriction of the use of  D5 as a solvent in the dry cleaning of 
textiles, leather and fur  of ten years . As regards medicina l and veterinary products,  
SEAC supported a seven -year deferr al of the restriction . This seven -year deferral  takes 
into account  the time necessary to substitute  the use of D 4, D5 and D6  in medicinal 
and veterinary products with alternative  substances or technologie s, as well as the time 
needed for qualification and registration  of such products . 
                                                 
4 https://echa.europa.eu/documents/10162/13641/note_to_echa_annex_xv_d6_en.pdf/722217b2 -95c1 -
a5a0 -90c5 -82f2afed48f9   
5 https://echa.europa.eu/documents/10162/039f5415 -d7a2 -b279 -d270 -0d07e18f6392  
6 https://echa.europa.eu/documents/10162/44c5f15a -a022 -5084 -762e -03bbb00599d5   
7 https://echa.europa.eu/documents/10162/a3e8195a -23d3 -5859 -6fdc-7805a3148b46    
EN 3  EN (11) SEAC also concurred with a number of derogation s proposed in the Annex XV 
dossier . SEAC agreed with t he derogation for the placing on the market of  D5 and D6 
for use in devices for the treatment  and care of scars and wounds, the prevention of 
wounds, and the care of stoma. SEAC also agreed with  the derogation for the placing 
on the market of  D5 for professional use in the cleaning or restoration of art and 
antiques , and with  the inclusion of a clearer description of the activities on industrial 
sites to which the restriction to the placing on the market of D4, D5 and D6 is not to 
apply . SEAC concurre d with the derogation for the placing on the market and the use 
of D5 as a solvent in dry cleaning systems of textile, leather and fur , under certain 
conditions . 
(12) Based on information on uses in mixtures and on enforcement  considerations , SEAC 
concurred wit h the suggested clarifications and further derogations  proposed in the 
Annex XV dossier  for certain mixtures that contain D4, D5 and D6 as residues from 
silicone polymers . 
(13) The Agency’s Forum for Exchange of Information on Enforcement, referred to in 
Article 76(1) , point (f), of Regulation (EC) No 1907/2006, was consulted during the 
restriction procedure and the Commission has taken its recommendations into account . 
(14) On 25 May 2020,  the Agency submitted the opinions of RAC and SEAC to the 
Commission.  
(15) The Commission concludes that there is an unacceptable risk arising from the 
emissions  of D4, D5 and D6 from  consumer and professional products and that the 
restriction  proposed by the Agency , with the changes suggested  by RAC and SEAC,  is 
the most appropria te Union -wide measure to address th at risk. 
(16) The Commission concurs with the conclusion , in RAC ’s and SEAC ’s opinions , that 
the proposed restriction is complementary and provides a logical extension to the 
existing restriction on the placing on the market o f D4 and D5 in wash -off cosmetic 
products, contain ed in entry 70 of Annex XVII to Regulation (EC) No 1907/2006 . In 
the interest of legal certainty and for  ease of reading , that entry  should be replaced in 
its entirety . 
(17) Stakeholders should be allowed sufficient time to take appropriate measures to comply 
with the proposed restriction . The Commission therefore proposes a  general deferral 
period of  two years , and longer deferral periods for specific uses . The Commission 
also concurs with the need for derogations for a number of specific uses . 
(18) As regards the deferral period for leave -on cosmetic products, the Commission  notes 
the high emissions from that product group and the conclusion by RAC that for vPvB 
and PBT substances , the length of the transitiona l period is the most critical element  
from a risk point of view , as more emissions occur the longer the transitional period is . 
Consequently, emissions of vPvB and PBT  substances into the environment should be 
minimised with a short transitional period . The Commission also notes the significant 
costs to industry to reformulate a high number of leave -on cosmetic products  per year. 
In view of the cost-effectiveness of the proposed restriction  for leave -on cosmetic 
products and the need to balance a high protection of human health and the 
environment with the minimisation of socio -economic impacts, the Commission 
concludes that a three -year deferral period for those  products is appropriate . 
(19) Regulation (EC) No 1907/2006 should therefore be amended acco rdingly.  
(20) The measures provided for in this Regulation are in accordance with the opinion of 
the Committee  established by Article 133 (1) of Regulation (EC) No 1907/2006 ,  
EN 4  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 Union . 
This Regulation shall be binding in its entirety  and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen