On 17 May 2024, the European Commission has approved and published Commission Regulation (EU) 2024/1328 to amend the Entry 70 of Annex XVII to REACH Regulation which concern the three substances octamethylcyclotetrasiloxane (D4, CAS No. 556-67-2), decamethylcyclopentasiloxane (D5, CAS No. 541-02-6) and dodecamethylcyclohexasiloxane (D6, CAS No. 540-97-6). The substance D6 is newly added in this entry. The amendment shall enter into force on 6 June 2024 and will apply after 6 June 2026.

Requirements

1. D4, D5 and D6 shall not be placed on the market after 6 June 2026
   1. as a substance on its own;
   2. as a constituent of other substances; or
   3. in mixtures
      in a concentration equal to or greater than 0.1% (1000 mg/kg) by weight of the respective substance.
2. D4, D5, and D6 shall not be used as a solvent for the dry cleaning of textiles, leather and fur after 6 June 2026.

Further transitional period for certain products

1. The content limits on D4, D5 and D6 in cosmetic products shall apply after 6 June 2027. However, the content limits on D4 and D5 in wash-off cosmetic products (as defined in Article 2(1), point (a), of the EU Cosmetics Regulation (EC) No 1223/2009 that, under normal conditions of use, are washed off with water after application) have already applied after 31 January 2020.
2. The content limits on D4, D5 and D6 in devices (as defined in Article 1(4) of the EU Regulation (EU) 2017/745 and in Article 1(2) of the EU Regulation (EU) 2017/746), as well as medicinal products (as defined in Article 1, point 2, of the EU Directive 2001/83/EC), and in veterinary medicinal products (as defined in Article 4(1) of the EU Regulation (EU) 2019/6), shall apply after 6 June 2031.
3. The content limit and restriction on D5 as a solvent in the dry cleaning of textiles, leather and fur shall apply after 6 June 2034.

Derogations for certain products

1. For D4, D5 and D6 as a constituent of a silicone polymer on its own.
2. For D4, D5 or D6 as residues from silicone polymers and D4, D5 or D6 in a concentration equal to or less than 1% (10000 mg/kg) by weight of the respective substance in the mixture, for use in adhesion, sealing, gluing and casting.
3. For protective coatings (including marine coatings), the D4 content limit is 0.5% (5000 mg/kg), the D5 and D6 content limits are 0.3% (3000 mg/kg), respectively.
4. For D4, D5 or D6 used as adhesion promoters in a mixture, the D4, D5 and D6 content limits are 0.5% (5000 mg/kg), respectively.
5. For certain substances and mixtures for industrial uses, professional uses and laboratory uses, certain medical devices, certain horse utensils, 3D-printing, mould making, etc. the content limits on D4, D5 and D6 do not apply or mitigated.

The siloxanes D4, D5 and D6 are fluids that perform technical functions in cosmetic products, e.g., hair-conditioning agents, skin-conditioning agents (emollient) and as a solvent/diluent. They also have functions of anti-foaming, dewatering, anti-wrinkling and perfume release agent in the detergents and cleaning products. Besides, they are used as monomers for producing a large variety of silicone polymers and can be present at low concentrations in these substances as an impurity. D4, D5 and D6 were identified as SVHC (substances of very high concern) for their PBT (persistent, bioaccumulative and toxic) and vPvB (very persistent, very bioaccumulative) properties by the ECHA (European Chemicals Agency) in 2018.

Contact Windows

Hotline：0755-2602 0287
Susie.su@intertek.com

About Intertek

Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely.

www.intertek.com.cn