The regulatory story of silver in cosmetics has taken a significant turn. However, it is not a simple one.
In December 2025, the SCCS issued a new preliminary opinion on micron-sized particulate silver. Specifically, the committee found that this form of silver does not penetrate the skin. As a result, the SCCS now considers it safe for broad cosmetic use. This reverses its earlier negative assessment from June 2024.
But here is the catch. The EU regulation published just weeks later does not reflect this updated science. From 1 May 2026, the law will only permit micron-sized silver in four product types. This applies regardless of what the SCCS now says.
If you formulate with silver, you need to understand both the science and the law. Right now, they tell different stories.
How We Got Here
In September 2024, the EU classified silver (CAS No. 7440-22-4) as Toxic for Reproduction Category 2. This classification falls under the 22nd ATP to the CLP Regulation (Regulation EU 2024/2564). It takes effect on 1 May 2026.
Under Article 15(1) of the Cosmetics Regulation, this classification triggers an automatic ban. The only exception is if the SCCS evaluates the substance and confirms its safety.
In October 2023, the applicant submitted a dossier defending the safe use of micron-sized particulate silver. More precisely, the dossier covered MicroSilver BG as a conditioning agent. The SCCS then assessed the data and published its first opinion in June 2024 (SCCS/1665/24).
The verdict? Not safe — at least not for most product types.
The dermal absorption data caused the problem. The applicant had submitted an in-vitro pig skin study. However, the resulting systemic exposure estimates pushed the Margin of Safety below 100 for most product categories. Consequently, only eye shadow and oral products (lip balm, toothpaste, mouthwash) passed the safety threshold.
What Changed: The New Dermal Penetration Data
In August 2025, the applicant came back with substantially stronger evidence. The SCCS then reassessed the safety of micron-sized silver (SCCS/1687/25, adopted 17 December 2025).
The applicant submitted two key studies.
First, an ex-vivo study on porcine and human skin. Researchers used Time-of-Flight Secondary Ion Mass Spectrometry (ToF-SIMS) to track silver distribution. They applied a 0.3% MicroSilver BG cream for 24 hours. In all samples, silver remained confined to the skin surface and upper stratum corneum. Importantly, no silver was detected in the viable epidermis or dermis.
Second, a 28-day human volunteer study with 10 subjects. This study combined tape stripping with ICP-MS analysis, a mass balance experiment, and punch biopsy analysis with ToF-SIMS. Participants applied the cream daily for 28 days at 2 mg/cm². The results showed a clear declining concentration gradient from outer to deeper stratum corneum layers. Furthermore, no evidence of accumulation appeared over time. Biopsy analysis confirmed that silver existed exclusively in the stratum corneum. No signal appeared in viable skin tissue.
Based on these findings, the SCCS agreed that MicroSilver BG particles do not penetrate beyond the stratum corneum. Additionally, the committee accepted that a 0.5% ionisation rate is a conservative estimate of silver ion release in cosmetic formulations.
The Revised SCCS Conclusion
In light of this new evidence, the SCCS now considers micron-sized particulate silver [100 nm < particle diameter < 1 mm] safe when used at up to 0.2% in rinse-off products and up to 0.3% in leave-on products.
This conclusion covers the full range of product categories in Tables 5 and 6 of the opinion. These include face creams, body lotions, hand creams, non-spray and pump-spray deodorants, foot creams, after-shave, eye shadow, lip balm, toothpaste, mouthwash, and shampoo.
Moreover, the recalculated aggregate Margin of Safety across all exposure routes comes out at 271. This sits comfortably above the 100 threshold.
However, three important caveats apply:
1. The SCCS excluded propellant-based sprays. The applicant did not cover these formats. Therefore, the SCCS has not assessed them.
2. Nano silver (≤100 nm) falls outside this opinion. It has different physicochemical and toxicological characteristics. As a result, it remains prohibited.
3. This opinion is still preliminary. The comment period ran until 23 February 2026. The SCCS has not yet adopted the final version.
The Problem: The Law Has Not Caught Up
This is where it gets frustrating for formulators.
The Commission adopted Regulation (EU) 2026/78 on 12 January 2026. That was just three weeks after the SCCS published its favourable preliminary opinion. However, the Commission drafted this regulation on the basis of the first SCCS opinion from June 2024 — the one that found silver unsafe for most uses. Simply put, the legislative timetable did not allow the Commission to incorporate the reversal.
As a consequence, the current regulation is far more restrictive than what the science now supports.
Here is what the regulation says, applicable from 1 May 2026:
Banned (Annex II): The regulation prohibits silver nano (1–100 nm) and silver massive (≥1 mm) in cosmetic products.
Permitted as a colorant (Annex IV): The regulation allows micron-sized silver powder (CI 77820) only in lip products and eye shadow, at a maximum of 0.2%.
Permitted as a restricted substance (Annex III): The regulation allows micron-sized silver powder in toothpaste and mouthwash only, at a maximum of 0.05%.
That is it. Four product types. Everything else — face creams, body lotions, deodorants, shampoos, hand creams, foot creams, after-shave — remains off the table until the Commission amends the regulation.
To close this gap, the Commission will need to adopt a further amending regulation. First, the SCCS must finalise its opinion. Then the Commission must draft, consult on, and adopt the amendment through the Standing Committee. This process could take many months, possibly longer.
What Formulators Need to Do
First, comply with the law as published. If you use micron-sized silver in anything other than eye shadow, lip products, toothpaste, or mouthwash, you must reformulate or withdraw by 1 May 2026. A favourable SCCS preliminary opinion does not override published legislation.
Second, plan ahead — but do not jump the gun. The science clearly supports broader use. Once the SCCS finalises its opinion and the Commission adopts an amendment, the permitted product types should expand. However, that process will take time.
Third, watch for updates. The key milestones to track are the finalisation of SCCS/1687/25 and the subsequent Commission amendment to Annexes III and IV.
In summary, the SCCS has confirmed that micron-sized silver does not penetrate the skin. The safety case is now strong. But the regulatory machinery moves slower than the science. Until it catches up, the restrictions stand.
References
SCCS/1687/25 — Scientific advice on Silver used in cosmetic products, preliminary version of 17 December 2025. View opinion
SCCS/1665/24 — Opinion on the safety of Silver used in cosmetic products, final version of 20 June 2024. View opinion
Commission Regulation (EU) 2026/78 of 12 January 2026. View regulation
Commission Delegated Regulation (EU) 2024/2564 (22nd ATP to CLP Regulation). View regulation