On 16 May 2024, the European Commission adopted Regulation (EU) 2024/1328, amending Annex XVII to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH). The new regulation specifically targets octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecamethylcyclohexasiloxane (D6), introducing tighter restrictions on their use due to their environmental impact.
Background and Rationale
Previous Restrictions and Identification as SVHCs
The regulation follows the Commission's previous restrictions on D4 and D5 in wash-off cosmetic products, established in January 2018. In June 2018, D4, D5, and D6 were identified by the European Chemicals Agency's (ECHA) Member State Committee as substances of very high concern (SVHCs) due to their very persistent and very bioaccumulative (vPvB) properties. D4 was additionally identified for its persistent, bioaccumulative, and toxic (PBT) properties.
Risk Assessment and Need for Further Action
The ECHA's Risk Assessment Committee (RAC) and Socio-Economic Assessment Committee (SEAC) concluded that the risks posed by these substances in leave-on cosmetic products and other consumer and professional products were not adequately controlled. The wide dispersive use of these chemicals in such products leads to significant environmental releases, particularly into aquatic and atmospheric compartments.
Key Provisions of the Regulation
General Restrictions
The new regulation stipulates that from 6 June 2026, D4, D5, and D6 cannot be placed on the market as substances, constituents, or in mixtures in concentrations equal to or greater than 0.1% by weight. Additionally, their use as solvents in dry cleaning will be prohibited from this date.
Deferrals and Derogations
Recognizing the time needed for industry adjustments, the regulation includes several deferrals:
- Cosmetic Products: Non-wash-off cosmetic products must comply by 6 June 2027.
- Medical Devices: Compliance for these devices is required by 6 June 2031.
- Medicinal and Veterinary Products: A seven-year deferral is granted, pushing compliance to 6 June 2031.
- Dry Cleaning: The use of D5 as a solvent in dry cleaning is deferred until 6 June 2034.
Specific Uses and Exemptions
Certain uses are exempt from the restrictions under controlled conditions, including:
- Industrial uses in silicone polymer production, non-metal surface treatment, and as laboratory reagents.
- Use in medical devices for scar and wound care, and stoma care.
- Professional use in art and antique restoration.
Implementation and Enforcement
The regulation will enter into force 20 days after its publication in the Official Journal of the European Union. The Commission emphasizes the necessity for industry stakeholders to take appropriate measures promptly to comply with the new requirements.
