On May 16, 2024, the European Commission amended 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). Under the 2006 REACH regulation, the amendment imposes stricter limits on the use of these chemicals in wash-off cosmetics and other consumer and professional products.
Prior Restriction Requirements
| Substance Name | Requirements |
| 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 in wash-off cosmetic products in a concentration equal to or greater than 0.1 % by weight of either substance, after 31 January 2020. 2. For the purposes of this entry, “wash-off cosmetic products” means cosmetic products as defined in Article 2 (1) (a) of Regulation (EC) No 1223/2009 that, under normal conditions of use, are washed off with water after application. |
New Restriction Requirements
| Substance Name | Modifications |
| 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 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. |
Insights
D4, D5, and D6 are classified as SVHCs with vPvB properties. D4 is recognized for its PBT characteristics, and when D5 and D6 contain 0.1% or more of D4, they too are classified as PBT. Given the inadequate risk control for products with PBT and vPvB attributes, restrictions are the most appropriate management strategy.
Following the regulation of rinse-off products containing D4, D5, and D6, controls on wash-off products with these chemicals have been strengthened. Due to their broad applications, restrictions on D5 in textile, leather, and fur dry cleaning, as well as on D4, D5, and D6 in pharmaceuticals and veterinary medicines, have been postponed.
Given the extensive use of D4, D5, and D6 in polysiloxane production without specific restrictions, concentration thresholds for mixtures with these residues have been defined. Companies should carefully review the relevant provisions to ensure that the products are not subject to restrictive conditions.
The restrictions on D4, D5, and D6 minimally impact the domestic silicone industry, as companies can comply with most regulations by managing these substances’ residues in production.
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Source from CIRS
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