The Member State Committee (MSC) has agreed to identify two new substances as substances of very high concern (SVHCs) under the REACH Regulation. The decision, made during MSC's 90th meeting from 10–12 June 2025 in Helsinki, targets decamethyltetrasiloxane (L4) and 1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane (M3T) due to their very persistent and very bioaccumulative (vPvB) characteristics.
The Candidate List update is scheduled for 25 June 2025, creating immediate legal obligations for companies involved in manufacturing, importing, or using these substances.
Understanding the Substances and Their Impact
L4 (EC 205-491-7) and M3T (EC 241-867-7) are linear siloxanes commonly used in cosmetics, personal care products, lubricants, and various industrial formulations. Their identification as SVHCs stems from scientific assessments showing significant environmental persistence and potential for bioaccumulation in aquatic organisms.
The SVHC status mandates companies to:
- Notify ECHA if the substances are present above 0.1% w/w in articles.
- Provide safe use information to downstream users.
- Respond to consumer requests within 45 days.
Next Steps in REACH
In addition to SVHC identifications, MSC reviewed ECHA’s draft 12th recommendation for Annex XIV (the Authorisation List). The committee expressed support for including:
- Melamine
- Phosphorodithioate derivatives used as additives in lubricants
- Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide
- Barium diboron tetraoxide
These substances are being considered for restriction of use unless authorised. The final opinion will be adopted via written procedure and forwarded to the European Commission by the end of 2025.
Compliance and Supply Chain Readiness
For regulatory professionals, this update reinforces the urgency of monitoring SVHC developments. Companies must not only ensure REACH compliance but also consider supply chain risks, customer communication protocols, and potential substitution strategies.
ECHA also previewed evaluation process reforms, including:
- Alignment with updated OECD test guidelines
- Enhanced protocols for substances registered in lower tonnage bands
- Improvements to testing proposal evaluations and degradation study quality
These procedural changes could influence how data is interpreted and compliance decisions are made in future dossier assessments.
