In May 2025, the European Commission notified the World Trade Organization (WTO) of Omnibus Act VIII, introducing new bans and restrictions on substances classified as CMR (carcinogenic, mutagenic, or toxic for reproduction). Among the affected ingredients, the amendment included silver in various particle sizes across Annex II, Annex III, and Annex IV of the EU Cosmetics Regulation.
The new restrictions prohibit the use of silver in its micron-sized form across multiple product categories. These restrictions – based on an SCCS opinion from 2024 – are coming into force on 1 May 2026. However, in April 2026, the SCCS – provided with new studies and additional information – published a reassessment that is expected to lead to a reversal of the ban in certain product categories in favour of more general restrictions in leave-on and rinse-off products.
Silver: regulatory framework and cosmetic uses
Silver (CAS No. 7440-22-4) has several applications in cosmetic products. It is commonly used in deodorants, mouthwashes, and toothpastes for its antibacterial and odour-control properties. Additionally, silver functions as a conditioning agent and as a colourant, providing metallic or shimmering effects in products such as eyeshadows, highlighters, nail polishes, and body powders.
Following the classification recommendation by the European Chemicals Agency’s Risk Assessment Committee (RAC) identifying silver as a CMR substance – and based on the 2024 opinion of the Scientific Committee on Consumer Safety (SCCS) which concluded that silver is not safe at concentrations up to 0.2% in rinse-off products and 0.3% in leave-on products – the European Commission adopted Regulation (EU) 2026/78 (Omnibus Act VIII). This regulation restricts the use of silver and will apply from 1 May 2026.
Current restrictions under Omnibus Act VIII
- Silver (nano) [1 nm < particle diameter ≤ 100 nm]
- Silver (massive) [particle diameter ≥ 1 mm]
Under the added entry 379 of Annex III, micron-sized particulate silver (powder) [100 nm < particle diameter < 1 mm] can be used exclusively in the following product categories at the below concentrations:
- Toothpaste: Maximum concentration of 0.05%
- Mouthwash: Maximum concentration of 0.05%
As a colourant, silver of the same particle size may be used under the following conditions set out in Annex IV:
- Lip products: Maximum concentration of 0.2%
- Eye shadow: Maximum concentration of 0.2%
New 2025 SCCS opinion
In August 2025, the European Commission received an updated dossier including new dermal penetration studies. These studies aimed to demonstrate the safe use of micron-sized particulate silver.
As a result, the Commission requested a new assessment from the SCCS. In its preliminary scientific advice (SCCS/1687/25, adopted preliminarily on 17 December 2025, and in its final version in April 2026), the SCCS concluded that micron-sized particulate silver (100 nm < particle diameter < 1 mm) does not penetrate the skin and can be considered safe when used at concentrations up to:
- 0.2% in rinse-off products
- 0.3% in leave-on products
However, this conclusion does not apply to propellant-based spray products, as these uses were not covered in the submitted dossier and therefore were not assessed for safety.
Consequently, entry 379 for silver in Annex III of the Cosmetics Regulation – as amended by Omnibus Act VIII – is expected to be revised.
Next steps and compliance pathways
Until any formal amendment is adopted, manufacturers are expected to remain compliant with the requirements set out in Omnibus Act VIII.
The European Commission is currently working on an urgent revision of the silver entry to reflect the latest SCCS advice. It is possible that the European Commission may resort to the urgency procedure referred to in Article 32(4) of the Cosmetics Regulation, allowing it to adopt an immediately applicable implementing act that temporarily bypasses the ordinary procedure while the standard committee review is carried out.
National authorities and stakeholders are anticipating further guidance.
References
SCCS. (2026). Scientific Advice on Silver used in cosmetic products. Retrieved on 24/04/2026.
WTO. (2025). Draft Commission Regulation amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction. Retrieved on 21/05/2025.
WTO. (2025). Draft Annex to the Commission Regulation amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetics products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction. Retrieved on 21/05/2025.
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