Changes to silver restrictions in EU cosmetics

EU proposes broader permitted use of silver in cosmetic products

The European Commission is proposing to broaden the permitted use of micron-sized silver powder in cosmetic products following new scientific advice from the Scientific Committee on Consumer Safety (SCCS).

On 30 July 2026, the European Commission notified the World Trade Organization (WTO) of a draft amendment to Regulation (EC) No 1223/2009 concerning the use of silver in cosmetics.

If adopted, the amendment will expand the product categories in which certain forms of silver powder may be used and increase the maximum permitted concentrations in several applications.

Why are the silver restrictions changing?

Silver (CAS No. 7440-22-4; EC No. 231-131-3) has been classified as toxic for reproduction, Category 2.

Consequently, Commission Regulation (EU) 2026/78 (Omnibus VIII) introduced new restrictions for silver, applicable from 1 May 2026.

For micron-sized silver powder with a particle diameter of 100 nm < particle diameter < 1 mm, Omnibus VIII permitted its use under Annex III only in toothpaste and mouthwash at up to 0.05%.

As a colourant (CI 77820) under Annex IV, silver powder was permitted in lip products and eye shadows at up to 0.2%.

However, additional dermal penetration data were subsequently submitted to the European Commission. Following an assessment of these new data, the SCCS concluded in its final scientific advice SCCS/1687/25 that the assessed micron-sized particulate silver does not penetrate the skin and can be considered safe under broader conditions of use.

What is changing?

The Commission’s draft amendment would significantly expand the permitted uses of silver powder.

Under the proposed Annex III, entry 379, silver powder could be used as follows:

Product categoryProposed maximum concentration
Rinse-off products0.2%
Oral products, except children’s mouthwash0.2%
Mouthwash for children0.05%
Leave-on products0.3%
Nail products0.3%

The amendment would therefore replace the much narrower Omnibus VIII provisions, which limited Annex III uses to toothpaste and mouthwash at 0.05%.

There are, however, important conditions. The new provisions apply specifically to silver powder with a porous and sintered particle structure, and the ingredient must not be used in applications that may lead to exposure of the end user’s lungs by inhalation.

Changes for silver as a colourant

The Commission is also proposing to amend Annex IV, entry 142, which covers silver as the colourant CI 77820.

Currently, the relevant silver powder is permitted as a colourant in lip products and eye shadows at a maximum concentration of 0.2%.

Under the proposed amendment, it could instead be used in:

Product categoryProposed maximum concentration
Leave-on products0.3%
Nail products0.3%

The same requirements concerning the porous and sintered particle structure and avoidance of applications resulting in lung exposure by inhalation would apply.

What does this mean for cosmetic companies?

The proposed changes would allow the relevant form of silver powder to be used in a considerably wider range of cosmetic products.

However, compliance cannot be determined from the INCI name alone. Companies should verify the particle size and physical structure of the silver raw material and obtain appropriate supporting documentation from their supplier.

The product category, concentration and potential for inhalation exposure must also be considered.

Companies that reformulated products or discontinued certain uses of silver following Omnibus VIII should therefore review whether those products could fall within the new conditions.

When will the changes apply?

The amendment notified to the WTO on 30 July 2026 is currently a draft Commission Regulation and has not yet been published in the Official Journal of the European Union.

According to the draft, the amended provisions are intended to apply from 1 May 2026, corresponding to the application date of the silver restrictions introduced by Omnibus VIII.

Cosmetic companies using silver should therefore monitor the final adoption and publication of the Regulation.

Need help checking your products?

If your products contain Silver or CI 77820, CE.way can review the formulation and raw material documentation to determine whether the ingredient complies with the applicable EU requirements.

We can also assist with CPSR preparation and updates, PIF preparation, formula and label reviews, CPNP notification and EU Responsible Person services.

Contact us to discuss the compliance of your cosmetic products.

Sources

Commission Regulation (EU) 2026/78 – Omnibus VIII.

Scientific Committee on Consumer Safety (SCCS) – Scientific Advice on Silver (CAS/EC No. 7440-22-4/231-131-3) used in cosmetic products, SCCS/1687/25, final version adopted 26 March 2026, corrigendum 20 May 2026.

European Commission / WTO – Draft Commission Regulation amending Regulation (EC) No 1223/2009 as regards the use in cosmetic products of silver, notified 30 July 2026.