The EU has revised the restriction requirements for D4, D5, and D6

On 17 May 2024, The Official Journal of the European Union published (EU) No 2024/1328, revising entry 70 of the restricted substance list in Appendix XVII of the REACH Regulation.The new regulations have established restrictions on octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecylcyclohexasiloxane (D6) in substances or mixtures. This revision will take effect on the 20th day after its publication (June 6, 2024).

Legislative background：

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.

RAC adopted its opinion , confirming that 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.

The specific restrictions are as follows:

Restricted substance

‘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

Requirement for restriction

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 to or greater than 0,1 % by weight of the respective substance after 6 June 2026.

2.Shall not be used as a solvent for the dry cleaning of textiles, leather and fur after 6 June 2026.

3.By way of derogation:

(a)for D4 and D5 in wash-off cosmetic products, paragraph 1, point (c), shall apply after 31 January 2020.
For the purposes of this point, “wash-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 (*1) that, under normal conditions of use, are washed off with water after application;
(b)for all cosmetic products other than the ones mentioned in paragraph 3(a), paragraph 1 shall apply after 6 June 2027;
(c)for devices as defined in Article 1(4) of Regulation (EU) 2017/745 of the European Parliament and of the Council (*2) and in Article 1(2) of Regulation (EU) 2017/746 of the European Parliament and the Council (*3), paragraph 1 shall apply after 6 June 2031;
(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 (*4), paragraph 1 shall apply after 6 June 2031;
(e)for D5 as a solvent in the dry cleaning of textiles, leather and fur, paragraphs 1 and 2 shall apply after 6 June 2034.

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 industrial uses:
—as a monomer in the production of silicone polymer,
—as an intermediate in the production of other silicon substances,
—as a monomer in polymerisation,
—in the formulation or (re)packing of mixtures,
—in the production of articles,
—in non-metal surface treatment;
(b)placing on the market of D5 and D6 for use as devices, as defined in Article 1(4) of Regulation (EU) 2017/745, for the treatment and care of scars and wounds, the prevention of wounds and the care of stoma;
(c)placing on the market of D5 for professional use in the cleaning or restoration of art and antiques;
(d)placing on the market of D4, D5 and D6 for use as laboratory reagent in research and development activities carried out under controlled conditions.

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 silicone polymer on its own,
—as a constituent of a silicone polymer in 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 concentration equal to or less than 0,5 % by weight, or D5 or D6 in a concentration equal to or less than 0,3 % by weight of either substance in the mixture for use as protective coatings (including marine coatings);
(c)D4, D5 or D6 in a concentration 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 and in Article 1(2) of Regulation (EU) 2017/746, other than the devices referred to in paragraph 6(d);
(d)D5 in a concentration 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 concentration 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 insoles for horses, or as horseshoes;
(f)D4, D5 or D6 in a concentration 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 uses 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 manufacturing 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, paragraphs 1 and 2 shall not apply to the placing on the market for 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.

CTT tips：
The international community has higher restrictions on harmful chemical substances, and enterprises are facing increasing control requirements.Enterprises exporting to Europe should raise their risk awareness and respond early. CTT will continue to monitor the dynamics of REACH regulations and provide you with the latest information.

Original link：Regulation - EU - 2024/1328 - EN - EUR-Lex (europa.eu)