European Commission Seeks Definitive Safety Verdict on Nano Silica in Cosmetics

The targeted nanomaterials are Hydrated Silica (nano), Pyrogenic Silica (nano), Silica Silylate (nano), and Silica Dimethyl Silylate (nano). These synthetic amorphous silica forms are commonly found in a wide range of cosmetic products such as skin care, make-up, and oral care items. Their functions include abrasive, absorbent, bulking, opacifying, and emulsion stabilising properties.

The review falls under Article 16 of Regulation (EC) No. 1223/2009, which requires a dedicated safety assessment for nanomaterials in cosmetics sold on the EU market.

Background: Unresolved Safety Concerns and Regulatory Gaps

The Commission’s renewed mandate follows previous assessments dating back to 2015, when the SCCS concluded that safety evaluations for these materials in nano form were inconclusive. Key gaps included inadequate characterisation of particle size, surface chemistry, and the absence of robust long-term toxicological data.

In 2019, the SCCS further determined that synthetic amorphous silica exhibits low solubility and qualifies as "insoluble or bio-persistent" under EU nanomaterial definitions. A 2021 advisory reiterated the need for comprehensive material-specific safety data, citing persistence and widespread use as areas of concern.

With industry resubmitting revised safety dossiers, the Commission now aims to close these long-standing data gaps and enable a final scientific opinion from the SCCS. The Committee is expected to evaluate whether these nano-forms of silica are safe at their proposed maximum concentrations or recommend alternative limits.

Regulatory Implications for Manufacturers and Stakeholders

This reassessment carries significant implications for manufacturers, raw material suppliers, and regulatory professionals throughout the cosmetics supply chain. A negative safety determination could trigger reformulation requirements or lead to restrictions under the Cosmetic Regulation.

Conversely, a positive safety opinion, based on credible, comprehensive data, could bring much-needed regulatory clarity, enabling continued use of nano-silica ingredients under defined conditions.

Professionals involved in product development, compliance, and toxicological risk assessment should monitor the SCCS’s conclusions closely. The final opinion, due within 12 months, could shape future authorisation pathways for nanomaterials in consumer products.