SCCS Confirms Safety of Micron-Sized Silver in Cosmetics at Defined Use Levels

4 weeks ago

The SCCS has concluded that micron-sized particulate Silver (100 nm < particle diameter < 1 mm) is safe for use in cosmetic products at concentrations up to 0.2 % in rinse-off and 0.3 % in leave-on formulations. This conclusion is based on new data showing that micron-sized Silver does not penetrate the skin, and therefore does not result in systemic exposure, even when taking into account its classification as toxic for reproduction Category 2. The opinion does not apply to propellant-based spray products, as inhalation exposure was not assessed

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The Scientific Committee on Consumer Safety (SCCS) has concluded that micron-sized particulate Silver is safe for use in cosmetic products at defined concentrations, despite its classification as toxic for reproduction Category 2, provided specific conditions are met.

This conclusion is part of the SCCS preliminary opinion on Silver used in cosmetic products, currently open for comments.

What the SCCS Assessed

The SCCS reassessed micron-sized particulate Silver with particle sizes:

100 nm < particle diameter < 1 mm

The assessment explicitly considered:

New data submitted by the applicant
The previous SCCS Opinion (SCCS/1665/24)
The CLP classification of Silver as Reprotoxic Category 2
Dermal exposure under cosmetic use conditions

SCCS Final Conclusion (Draft)

✅ Safety confirmed under specific conditions

Based on new data demonstrating that micron-sized particulate Silver does not penetrate the skin, the SCCS concludes that:

Micron-sized particulate Silver [100 nm < particle diameter < 1 mm] is safe
when used:

Up to 0.2 % in rinse-off cosmetic products
Up to 0.3 % in leave-on cosmetic products

These use levels are detailed in Tables 5 and 6 of the SCCS opinion 309.

This conclusion applies even when taking into account Silver’s classification as toxic for reproduction Category 2, because systemic exposure via dermal absorption is not expected.

Please note Aerosols and sprays remain out of scope

Separate safety justification would be required for such formats

Why This Matters for Formulators

This opinion provides regulatory clarity on a long-debated ingredient:

✔ Confirms dermal safety at realistic cosmetic use levels
✔ Supports continued use of micron-sized Silver in non-spray formats
✔ Clarifies that lack of skin penetration is the key safety driver
❌ Does not cover nanoparticles <100 nm
❌ Does not support use in propellant sprays

For formulators working on preservation concepts, antimicrobial systems, or aesthetic metallic effects, this conclusion is particularly relevant when designing EU-compliant products.