The regulatory framework for silver in cosmetics is changing again, only a few months after the date of application of Regulation (EU) 2026/78 (Omnibus VIII), which amended the EU Cosmetics Regulation (EC) No 1223/2009. On 30 July 2026, following the latest scientific assessment by the Scientific Committee on Consumer Safety (SCCS), the European Commission notified the WTO of a draft Regulation proposing to revise the silver restrictions introduced by Omnibus VIII.

From Omnibus VIII to a new proposal

Applicable from 1 May 2026, Omnibus VIII established specific restrictions for silver under Annex III, entry 379, following its classification under the EU harmonized hazard framework. The Regulation permits the use of silver powder, with particle sizes above 100 nm and below 1 mm, in toothpaste and mouthwash up to 0.05%. It also maintained specific provisions for silver used as the colorant CI 77820 under Annex IV, entry 142.

The SCCS identifies additional safe uses

The situation evolved with the revised SCCS Opinion SCCS/1687/25, which identified additional safe uses for micron-sized particulate silver based on new data indicating that this form of silver does not penetrate the skin.

Importantly, the SCCS assessment does not consider particle size alone, but evaluates micron-sized particulate silver – above 100 nm and below 1 mm – in relation to specific product types, concentrations and exposure scenarios.

This provided the scientific basis for reconsidering restrictions that had only recently entered into application and for proposing a less restrictive framework.

What could change?

The proposed relaxation would apply only to porous and sintered silver powder with particle sizes above 100 nm and below 1 mm. Applications that could lead to inhalation exposure, such as certain aerosol or propellant-based products, would remain excluded.

The draft Regulation would amend Annex III, entry 379, broadening the permitted uses of silver powder. The proposed framework would allow its use in:

• Rinse-off products: up to 0.2%;
• Oral products, except mouthwash intended for children: up to 0.2%;
• Mouthwash intended for children: up to 0.05%;
• Leave-on products: up to 0.3%;
• Nail products: up to 0.3%.

The proposal would also revise the provisions applicable to silver used as CI 77820 under Annex IV. In particular:

• Leave-on products: up to 0.3%;
• Nail products: up to 0.3%.

What does this mean for economic operators?

The proposed amendment would effectively reopen certain uses of silver that became restricted under Omnibus VIII, following the identification of additional safe exposure scenarios by the SCCS.

If adopted as currently proposed, the new Regulation could apply retroactively from 1 May 2026, potentially restoring compliance for certain products affected by the restrictions introduced by Omnibus VIII.

Until the amendment is formally adopted and published in the Official Journal of the European Union, however, the current Omnibus VIII requirements remain applicable.

For economic operators, the priority remains compliance with the current framework, while monitoring the proposed amendment and reviewing the specifications and documentation of silver-containing raw materials.

Next steps and regulatory timeline

The draft was notified to the WTO under the Technical Barriers to Trade (TBT) procedure on 30 July 2026, with the consultation period running until 28 September 2026.

The proposal will then proceed through the relevant EU regulatory process before formal adoption and publication.

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SOURCE
Notification Detail | TBT – European Commission
COMMISSION REGULATION (EU) 2026/78