SCCS/1687/25: Scientific Opinion on Silver in Cosmetics

The SCCS (Scientific Committee on Consumer Safety of the EU Commission) has adopted a new opinion on silver in cosmetics. In opinion SCCS/1687/25, the committee assesses microparticulate silver in several product categories as safe, provided defined maximum concentrations are observed. The assessment relies on new data that were not available for the previous opinion SCCS/1665/24.

Which substance is concerned

The subject of the assessment is silver with CAS number 7440-22-4 and EC number 231-131-3. The committee considers exclusively microparticulate silver. The opinion defines this via particle diameter: 100 nm < particle diameter < 1 mm. The nano range below 100 nm is therefore not covered by this assessment.

An important point in the background: silver is classified as reproductive toxicant category 2. The SCCS took this classification into account in its assessment. Decisive for the outcome were new data showing that microparticulate silver does not penetrate the skin. On this basis, the committee arrives at its safety assessment.

Which concentrations the SCCS considers safe

The committee considers microparticulate silver [100 nm < particle diameter < 1 mm] safe in the following cases:

According to the opinion, the same concentrations apply as safe for cosmetics intended for use on children. The exception is mouthwash: here the SCCS considers a concentration of up to 0.05 % safe.

Important restriction: aerosol sprays

The opinion explicitly does not apply to the use of microparticulate silver in propellant-based spray products. The reason: such applications were not part of the documentation submitted by the applicant. The SCCS therefore did not assess their safety. No conclusion is available for this product form.

On the Commission's second and third questions, namely an alternative safe maximum concentration and further scientific concerns, the opinion provides no additional information.

What the opinion means legally

An SCCS opinion is a scientific assessment. It is not yet applicable law. Only when the EU Commission implements the assessment through an amendment to Regulation (EC) No 1223/2009 do binding requirements arise, with maximum values, conditions of use, and transitional periods. The present opinion does not name any transitional periods or specific regulatory text. It provides the scientific basis on which a future legal act may be founded.

Manufacturers should monitor further developments. Whether and in what form the Commission will incorporate the concentrations into an annex of the Cosmetics Regulation is not yet determined at this point in time.

Timeline and correction

The SCCS adopted the opinion on 26 March 2026. A preliminary version is dated 17 December 2025. The opinion was published on 24 April 2026. On 20 May 2026, a corrigendum followed via written procedure. It adds missing values for hand cream in the table in Annex B, including a revised value for the subtotal SED and the MoS (Margin of Safety) for dermally applied products. The citable reference is SCCS/1687/25.

What manufacturers should check now

Anyone using or planning to use silver in formulations should first clarify whether it is microparticulate silver within the assessed size range. Particle size is decisive, since nanomaterial below 100 nm is not covered by this assessment. It is also advisable to conduct a stock-taking:

• Concentration: In what amount is silver contained in the formulation, and does this match the respective product category?
• Product form: Is it a rinse-off, leave-on, oral hygiene, or nail product? No assessment is available for aerosol sprays.
• Target group: Is the product intended for children? A lower value applies for mouthwash.
• Documentation: Are particle size and concentration properly documented in the product information file?

We at REGULARUS are monitoring further developments and are incorporating the scientific assessment into the safety assessment (CPSR under Annex I). As soon as the Commission proposes a legal act, we will review affected formulations as part of our amendment service. The full text of the opinion is available on the EU Commission's website at SCCS Scientific Advice on Silver. An overview of all opinions is available on the SCCS Opinions page.