On 30 July 2026, the European Commission notified the World Trade Organization (WTO) of a draft amendment to the Cosmetics Regulation concerning the use of silver in cosmetic products.
Amendments to Annex III
Annex III to the Cosmetics Regulation lists substances restricted in cosmetic products.
Entry 379 of Annex III has been amended to extend the permitted uses of silver (powder) [100 nm < particle diameter < 1 mm] (CAS No. 7440-22-4; EC No. 231-131-3). Under the amended entry, silver powder may be used in the following product categories and up to the corresponding maximum concentrations:
- Rinse-off products: 0.2%
- Oral products (except mouthwash for children): 0.2%
- Mouthwash for children: 0.05%
- Leave-on products: 0.3%
- Nail products: 0.3%
The restriction applies exclusively to silver powder with a porous and sintered particle structure. Furthermore, the ingredient must not be used in applications that may lead to inhalation exposure of the end user’s lungs.
Previous restrictions under Annex III and background to the amendment
Omnibus Act VIII, published in 2025, introduced Entry 379 into Annex III. Under this entry, micron-sized particulate silver (powder) [100 nm < particle diameter < 1 mm] could only be used in the following product categories and at the corresponding maximum concentrations:
- Toothpaste: 0.05%
- Mouthwash: 0.05%
In August 2025, however, the European Commission received an updated dossier containing new dermal penetration studies intended to demonstrate the safe use of micron-sized particulate silver. Following the assessment of this new data, the Scientific Committee on Consumer Safety (SCCS) adopted a revised opinion, the conclusions of which have now been implemented through this latest amendment.
As a result, the use of silver powder is no longer limited to toothpaste and mouthwash. The amendment significantly broadens the range of cosmetic products in which the ingredient may be used and increases the maximum permitted concentrations for certain product categories.
Amendments to Annex IV
Annex IV lists colourants permitted in cosmetic products.
Entry 142 of Annex IVhas also been amended to include silver (powder) [100 nm < particle diameter < 1 mm] (Colour Index No. 77820; CAS No. 7440-22-4; EC No. 231-131-3).
Under the amended entry, silver powder may be used as a colourant in the following product categories and up to the corresponding maximum concentrations:
- Leave-on products: 0.3%
- Nail products: 0.3%
The entry applies exclusively to silver powder with a porous and sintered particle structure. Furthermore, the ingredient must not be used in applications that may lead to inhalation exposure of the end user’s lungs.
Compared with the provisions introduced by Omnibus Act VIII, this amendment significantly expands the permitted uses of silver powder as a colourant. Previously, its use was restricted to lip products and eye shadows at a maximum concentration of 0.2%. Under the new amendment, silver powder may be used in all leave-on products and nail products, and the maximum authorised concentration has been increased to 0.3%. The amendment also reflects the latest SCCS assessment, which concluded that silver powder with a porous and sintered particle structure is safe under the revised conditions of use.
Deadline for compliance
The amendment will enter into force upon publication in the Official Journal of the European Union (OJEU) and will apply retroactively from 1 May 2026, which is the date on which Omnibus Act VIII became applicable.
Do you have questions on compliance of cosmetics in the EU, UK, USA, and Canada? Contact us here or at coslaw@obelis.net.
References
SCCS. (2026). Scientific Advice on Silver used in cosmetic products. Retrieved on 24/04/2026.
WTO. (2026). 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 silver. Retrieved on 31/07/2026.
WTO. (2026). 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 cosmetic products of silver. Retrieved on 31/07/2026.
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