EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2023) XXX  draft  
ANNEX  
 
ANNEX  
to the  
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),   
decamethylcyclopen tasiloxane (D5) and   
dodecamethylcyclohexasiloxane (D6)   
   
EN 1  EN ANNEX  
 
Entry 70 o f Annex XVII to Regulation (EC) No 1907/2006 is replaced by  the following : 
 
‘70. 
 
Octamethylcyclotetrasiloxane  (D4)  
 
CAS No 556-67-2 
EC No 209-136-7 
 
Decamethylcyclopentasiloxane 
(D5)  
 
CAS No 541-02-6 
EC No 208-764-9 
 
Dodecamethylcyclohexasiloxane  
(D6)  
 
CAS No 540-97-6 
EC No 208-762-8 
  
1. Shall not be placed on the market   
(a) as a substance on its own,  
(b) as a constituent of other substances,  
or 
(c) in mixtures  
in a concentration equal or greater than 0,1 
% by weight of the respective substance  
after [OP, please insert the date: 2 years 
after the entry into force of this amending 
Regulation ]. 
2. Shall not be used  as a solvent for the dry 
cleaning of textiles, leather and fur  after 
[OP, please insert the date: 2 years after 
the entry into force of this amending 
Regulation ]. 
3. By way of derogation : 
(a) for D4 and D5 in wash -off cosmetic 
products , paragraph 1 , point (c) , 
shall apply after 31 Januar y 2020 . 
For the purpose s of this point , 
‘was h-off cosmetic products’ means 
cosmetic products as defined in 
Article 2(1) , point (a), of Regulation 
(EC) No 1223/2009 of the European 
Parliament and of the Council (*) 
that, under normal conditions of use, 
are washed o ff with water after 
application;  
(b) for leave -on cosmetic products , as 
defined  in point (1)(b) of the 
Preamble of Annexes II to VI  to 
Regulation (EC) No 1223/2009 , 
paragraph 1 shall apply after [OP, 
please insert the date: 3 years after 
the entry into force of this amending 
Regulation ]; 
(c) for devices as defined in Article 1  
(4) of Regulation (EU) 2017/745  of 
the European Parliament and of the  
EN 2  EN Council (**), paragraph 1 shall apply 
after [OP, please insert the date: 5 
years after  the entry into force of this 
amending Regulation ]; 
(d) for medicinal products , as defined in 
Article 1 , point 2,  of Directive 
2001/83/EC, and for veterinary 
medicinal products , as defined in 
Article 4(1)  of Regulation (EU) 
2019/6 (***), paragraph 1 shall apply 
after [OP, please insert the date: 7 
years after the entry into force of this 
amending Regulation ]; 
(e) for D5 as a solvent in the dry 
cleaning of textiles, leather and fur, 
paragraphs 1 and 2 shall apply after 
[OP, please insert the date: 10 years 
after the entry into force of this 
amending Regulation ]. 
4. By way of derogation, paragraph 1  shall 
not apply to  the: 
(a) placing on the market of D4, D5 and 
D6 for the following industria l uses: 
– as a monomer in the 
production of silicone 
polymer ; 
– as an intermediate in the 
production of other silicon e 
substances ; 
– as a monomer in  
polymerisation ; 
– in the formulation or 
(re)packing of mixtures ; 
– in the production of articles ; 
– in non -metal surface treatment;  
– as laboratory reagent in 
research and development 
activities  carried out under 
controlled conditions ; 
(b) placing on the market of D5 a nd D6 
for use as device s, as defined in 
Article 1(4) of Regulation (EU) 
2017/745, for the treatmen t and care 
of scars and wounds, the  prevention 
of wounds and the care of stoma;   
EN 3  EN (c) placing on the market of D5 for 
professional use in the cleaning or 
restoration of art and antiques.  
5. By way of derogation, paragraph 1, point 
(b), shall not apply to the placing on the 
market of D4, D5 and D6 as a constituent 
of a polymer  where the polymer is for use 
in the formulat ion of  a mixture  derogated 
under  paragraph 6. 
6. By way of derogation, paragraph 1 , point 
(c), shall not apply to the placing on the 
market of mixtures that contain D4, D5 or 
D6 as residues from silicone polymers , 
under the following conditions : 
(a) D4, D5 or D6 in a concentration 
equal to or less than 1  % by weight  
of the respective  substance in the 
mixture , for use in adhesion, sealing, 
gluing and casting ; 
(b) D4 in a concen tration equal to or less 
than 0, 5 % by weight , or D5 or D6 in 
a concen tration equal to or less than 
0,3 % by weight  of either substance 
in the mixture  for use as protective 
coatin gs (including marine coatings);  
(c) D4, D5 or D6 in a concen tration 
equal to or less than 0, 2 % by weight  
of the respective substance in the 
mixture , for use as devices  as 
defined in Article 1 (4)  of Regulation 
(EU) 2017/745 ; 
(d) D5 in a concen tration equal to or less 
than 0, 3% by weight  in the mixture  
or D6 in a concentration equal to or 
less than 1  % by weight  in the 
mixture , for use as devices  as 
defined in Article 1(4)  of Regulation 
(EU) 2017/745 , for dental 
impression;  
(e) D4 in a concen tration equal to or less 
than 0, 2 % by weight  in the mixture , 
or D5 or D6 in a concentration equal 
to or less than 1 % by weight  of 
either substance in the mixture  for 
use as silicone insol es for horses, or 
as horseshoes;  
(f) D4, D5 or D6 in a concen tration  
EN 4  EN  equal to or less than 0, 5 % by weight  
of the respective  substance in the 
mixture , for use as adhesion 
promoters;  
(g) D4, D5  or D6 in a concentration 
equal to or less than 1 % by weight  
of the respective  substance in the 
mixture , for use in 3D -printing;  
(h) D5 in a concentration equal to or less 
than 1  % by weight  in the mixture  or 
D6 in a concentration equal to or less 
than 3  % by weight  in the mixture , 
for rapid prototyping and mould 
making, or high performance us es 
stabilised by quartz filler;  
(i) D5 or D6 in a concentration equal to 
or less than 1 % by weight  of either 
substance in the mixture , for use in 
pad printing, or  manufactur ing of 
printing pads;  
(j) D6 in a concentration equal to or less 
than 1 % by weight  of the mixture , 
for professional use in the cleaning 
or restoration of art and antiques . 
7. By way of derogation, paragrap hs 1 and 2 
shall not apply to the placing on the 
market f or use, or to the use, of D5 as a 
solvent in strictly controlled closed dry 
cleaning systems for textile, leather and 
fur, where the cleaning solvent is recycled 
or incinerated.  
(*) Regulation (EC) No 1223/2009 of the European 
Parliament and of the Council  of 30 November 2009 on 
cosmetic products (recast) (OJ L 342, 22.12.2009 , p. 59). 
(**) Regulation (EU) 2017/745 of the European Parliament 
and of the Council of 5 April 2017 on medical devices, 
amending Directive 2001/83/EC, Regulation (EC) No 
178/2002 and  Regulation (EC) No 1223/2009 and repealing 
Council Directives 90/385/EEC and 93/42/EEC (OJ  L 117, 
5.5.2017, p. 1 ). 
(***) Regulation 2019/6 of the European Parliament and of 
the Council of 11 December 2018 on cosmetic veterinary 
medicinal products and repealing Directive 2001/82/EC (OJ, 
L 004, 7.1.2019, p . 43).