New substances identified as persistent and bioaccumulative trigger regulatory obligations for manufacturers and suppliers.

The European Chemicals Agency (ECHA) has officially added two silicone-based substances, commonly used in cosmetics and personal care products, to the REACH Candidate List of substances of very high concern (SVHC). The decision is based on their classification as persistent and bioaccumulative, raising concerns about long-term environmental accumulation and potential risks to human health.

Regulatory Implications for Industry

Once included in the Candidate List, substances are subject to strict communication and notification requirements under the EU’s REACH Regulation (EC No. 1907/2006). Companies manufacturing, importing, or using these silicone ingredients must now:

• Notify customers down the supply chain about the presence of these substances in products or mixtures, particularly when concentrations exceed 0.1% weight by weight (w/w).
• Update Safety Data Sheets (SDS) and labeling information to reflect the inclusion of the substances on the Candidate List.
• Notify ECHA if these substances are present in articles, unless already registered for that use.

This step is also a precursor to possible future restrictions or authorisation requirements, depending on the outcomes of further regulatory evaluation.

Substances in Focus

Although ECHA has not yet publicly released the full chemical names in this update, the two silicone-based substances are widely recognized within the cosmetics industry for their functions as emollients, conditioning agents, or delivery vehicles. Their widespread use in skin creams, hair conditioners, and makeup formulations means the inclusion could have broad implications across the personal care sector.

Why This Matters

Persistent and bioaccumulative substances do not readily degrade in the environment and can build up in living organisms, leading to long-term exposure risks. Inclusion on the Candidate List signals regulatory intent to scrutinize and possibly phase out such substances unless suitable safety and risk management measures are in place.

Industry stakeholders—particularly cosmetic manufacturers, importers, and raw material suppliers—are urged to review their product formulations immediately and assess whether notification thresholds are exceeded. Failure to comply could result in enforcement actions by national authorities in EU Member States.

ECHA continues to review chemicals of concern regularly and is expected to update the Candidate List again later this year as part of its ongoing efforts to promote safer chemical use and substitution under the EU Green Deal and Chemicals Strategy for Sustainability.

Reference: ECHA’s Candidate List page.

 

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