Regulatory developments and upcoming changes
In May 2025, the European Commission notified the World Trade Organization (WTO) of Omnibus Act VIII, which introduces new prohibitions and restrictions on substances classified as CMR (carcinogenic, mutagenic or toxic for reproduction). Within this framework, silver has been incorporated into Annex II, Annex III and Annex IV of the EU Cosmetics Regulation, depending on particle size.
Under the current provisions, the use of micron-sized particulate silver is subject to significant limitations across various cosmetic product categories. These restrictions are based on the 2024 opinion of the Scientific Committee on Consumer Safety (SCCS) and are scheduled to apply as of 1 May 2026.
However, following the submission of new scientific evidence, the SCCS issued an updated assessment in April 2026. This revised opinion is expected to result in a regulatory update, potentially replacing certain prohibitions with more general concentration-based limits applicable to both leave-on and rinse-off product categories.
Silver: uses and regulatory background
Silver (CAS No. 7440-22-4) is widely used in cosmetic formulations due to its antimicrobial and deodorising properties. It is commonly found in products such as deodorants, mouthwashes and toothpaste. In addition to its functional role, silver is also used as a conditioning agent and as a colourant, providing metallic or shimmering effects in decorative cosmetics.
Following the classification proposal of silver as a CMR substance by the European Chemicals Agency (ECHA) Risk Assessment Committee (RAC), and the SCCS 2024 conclusion that silver is not considered 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).
Current restrictions under Omnibus Act VIII
The current regulatory status of silver is as follows:
Annex II (Prohibited substances):
- Silver (nano) [1 nm < particle diameter ≤ 100 nm]
- Silver (massive) [particle diameter ≥ 1 mm]
Annex III (Restricted substances – Entry 379):
Micron-sized particulate silver (powder form) [100 nm < particle diameter < 1 mm] is permitted only under specific conditions:
- Toothpaste: up to 0.05%
- Mouthwash: up to 0.05%
Annex IV (Colourants):
The same particle size of silver may be used as a colourant under the following limits:
- Lip products: up to 0.2%
- Eye shadow: up to 0.2%
Updated SCCS opinion (2025–2026)
In August 2025, the European Commission received a revised dossier including new dermal penetration data aimed at supporting the safe use of micron-sized particulate silver.
Following this, the SCCS published a preliminary opinion in December 2025 and finalised its assessment in April 2026 (SCCS/1687/25). The conclusion states that:
- Micron-sized particulate silver does not penetrate the skin barrier
- It may be considered safe at the following concentrations:
- Up to 0.2% in rinse-off products
- Up to 0.3% in leave-on products
However, this safety assessment does not extend to propellant-based spray formulations, which were not covered by the submitted data.
Accordingly, Entry 379 of Annex III is expected to be revised in line with the updated scientific opinion.
Next steps and compliance considerations
Until any formal amendment enters into force, manufacturers are required to continue complying with the existing requirements set out under Omnibus Act VIII.
The European Commission is currently working on an expedited revision of the silver restrictions to align the legislation with the latest SCCS conclusions. In this context, the urgency procedure under Article 32(4) of the Cosmetics Regulation may be applied, allowing for the adoption of an implementing act ahead of the standard legislative process.
Further guidance from the European Commission and national competent authorities is anticipated in the coming period.