The European Union’s Scientific Committee on Consumer Safety (SCCS) has released new preliminary scientific advice on the use of micron-sized particulate silver in cosmetic products, marking a significant regulatory development for the cosmetics industry. The updated assessment reverses earlier safety concerns and confirms that micron-sized silver can be safely used within defined concentration limits, based on robust new dermal penetration data.
Background: Why Silver Came Under Scrutiny
Silver (CAS No. 7440-22-4) is widely used in cosmetics as a colorant (CI 77820) and as a conditioning or antimicrobial-supporting agent. However, following a 2023 opinion from ECHA’s Risk Assessment Committee (RAC) recommending classification of silver as Toxic for Reproduction Category 2, its continued use in cosmetics required reassessment under Article 15 of EU Cosmetics Regulation (EC) No. 1223/2009.
In its earlier opinion (SCCS/1665/24, June 2024), the SCCS concluded that micron-sized particulate silver was not safe at concentrations of 0.2% in rinse-off and 0.3% in leave-on products, primarily due to uncertainties around dermal absorption and systemic exposure.
What Changed? New Dermal Penetration Evidence
In 2025, updated data were submitted to the European Commission, focusing specifically on skin penetration and bioavailability. The SCCS carefully evaluated:
- Ex vivo studies using porcine and human skin
- Human volunteer studies involving repeated application over 28 days
- Advanced analytical techniques including Time-of-Flight Secondary Ion Mass Spectrometry (ToF-SIMS) and ICP-MS
Key Scientific Findings
The new evidence consistently demonstrated that:
- Micron-sized silver particles do not penetrate beyond the stratum corneum
- No silver, metallic or ionic, was detected in the viable epidermis or dermis
- Even under worst-case exposure conditions (high dose, occlusion, repeated application), silver remained confined to the outermost skin layers
- No accumulation was observed after prolonged daily use
According to SCCS guidance, substances retained in the stratum corneum are not considered systemically available, significantly reducing toxicological concern.
Ionic Silver: Conservative Risk Assessment Applied
While particulate silver itself does not penetrate the skin, the SCCS conservatively assessed exposure to silver ions released from particles:
- Ionisation rate assumed: 0.5% (conservative estimate)
- Dermal absorption of silver ions: 0.1%
- Oral absorption (for lip and oral care products): 5%
Using these assumptions, aggregated systemic exposure doses remained well below toxicological thresholds, including the most conservative NOAEL derived from long-term animal studies.
SCCS Final Conclusions
Based on the newly submitted data, the SCCS concludes that:
- Micron-sized particulate silver (100 nm < particle diameter < 1 mm) is safe
- Permitted concentrations:
- Up to 0.2% in rinse-off cosmetic products
- Up to 0.3% in leave-on cosmetic products
- These conclusions do not apply to propellant-based spray products, as inhalation risks from such formulations were not assessed
No additional scientific concerns were identified for the approved uses.
Regulatory and Industry Impact
This updated SCCS advice provides much-needed regulatory clarity for cosmetic manufacturers using micron-sized silver. Importantly:
- The material is not classified as a nanomaterial, avoiding additional nano-specific regulatory burdens
- The opinion supports continued use under controlled conditions, even in light of silver’s reproductive toxicity classification
- Safety evaluations now clearly distinguish between particulate silver and systemically available silver ions
Looking Ahead
As this advice is currently preliminary, stakeholders should monitor for final adoption and any subsequent amendments to EU cosmetic annexes. Nonetheless, the opinion sets a strong scientific precedent, reinforcing the importance of high-quality dermal absorption data in cosmetic risk assessment.
Source:
SCCS (Scientific Committee on Consumer Safety), Preliminary Scientific Advice on Silver (CAS No. 7440-22-4) used in cosmetic products, SCCS/1687/25, adopted 17 December 2025.
