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Regulation & Compliance

SCCS Clears Micron-sized Particulate Silver at 0.3% in Leave-on Cosmetics

SCCS final opinion SCCS/1687/25 clears micron-sized particulate Silver up to 0.3% in leave-on and 0.2% in rinse-off cosmetics, reversing the 2024 rejection and excluding spray products.

By Rebecca Stone · · 3 min read · 616 words

Composition

  1. April 24, 2026: SCCS published final opinion SCCS/1687/25 on Silver (CAS 7440-22-4)
  2. Safe use limits: 0.3% leave-on, 0.2% rinse-off, 0.3% nail, 0.2% oral hygiene, 0.05% children's mouthwash
  3. Reverses June 2024 rejection (SCCS/1665/24) following a new ex vivo and human-volunteer dermal-penetration dossier submitted in August 2025
  4. From May 1, 2026, massive silver, silver powder and nano silver fall under Category 2 CMR (toxic for reproduction) in the EU
  5. Propellant-based spray applications are excluded from the SCCS assessment

The EU's Scientific Committee on Consumer Safety has cleared micron-sized particulate Silver (CAS 7440-22-4) for use at up to 0.3% in leave-on cosmetic products and 0.2% in rinse-off formats, according to final opinion SCCS/1687/25, published April 24, 2026.

The conclusion reverses the committee's June 2024 verdict (SCCS/1665/24), which had deemed the same particle size range unsafe at those concentrations. The change follows an August 2025 dossier from the applicant that paired ex vivo skin samples with human volunteer data. The combined studies demonstrate that particles in the 100 nm to under 1 mm window remain on or in the stratum corneum and do not reach systemic circulation under normal use conditions.

What changed from the 2024 opinion?

Two years ago, the SCCS restricted micron-sized particulate silver to eyeshadows and oral-exposure products (lip balm, toothpaste, mouthwash). The new assessment broadens that envelope across almost every rinse-off and leave-on category, including children's products at the same ceilings, while tightening one specific format.

For oral hygiene, the safe level is 0.2%; for nail products, 0.3%. Children's cosmetics follow the adult limits, with one exception: the SCCS caps mouthwash at 0.05%, half the level adult oral-hygiene products could otherwise carry.

Which applications fall outside the scope?

The opinion explicitly excludes propellant-based spray products. The applicant did not provide safety data for that delivery form, and the SCCS declined to extrapolate. Formulators working on aerosol deodorants, spray antiperspirants or dry shampoos containing metallic-effect silver will need to wait for a separate submission or pursue alternative pigments.

The particle range covered, 100 nm to under 1 mm, marks the crucial boundary. Colloidal nano-silver (1–100 nm) remains prohibited in the EU under Annex II, entry 1727 of Regulation (EC) No. 1223/2009.

What does the May 1 CMR deadline mean for compliance?

Effective May 1, 2026, massive silver (≥1 mm), silver powder (100 nm to under 1 mm) and nano silver (1–100 nm) will sit under Category 2 CMR — "toxic for reproduction" — in the EU Cosmetics Regulation. That classification traces back to a February 2023 recommendation from ECHA's Risk Assessment Committee.

The SCCS clearance therefore operates as a narrow carve-out within a broader restrictive framework. Brand owners and contract manufacturers should audit INCI declarations now: any silver raw material sitting above the new ceilings, or used in spray formats, risks non-compliance the moment the CMR entry takes effect.

Why does Silver still appear in eyeshadow and nail polish?

Silver remains an authorized colorant in the EU under CI 77820, listed in Annex IV, entry 142 of the Cosmetics Regulation. Suppliers commonly use it in eyeshadows, highlighters, nail polishes and body powders for metallic or shimmery effects, and report it as a conditioning agent in rinse-off and leave-on products.

The 2024 assessment presented the colorant in a more restrictive light; the new dermal-penetration evidence has shifted the safety balance for the micron-sized fraction.

How does the position align with other markets?

In China, Silver is listed in the Inventory of Existing Cosmetic Ingredients in China I (IECIC I) under entry 07927 and in the List of Colorants Allowed for Use in Cosmetic Products as CI 77820, with an approved scope covering all cosmetic product types. Exporters reformulating to the EU ceilings should verify that Chinese-market equivalents do not exceed the new EU limits when the same SKU ships to Europe.

The next data point to watch: any applicant submission covering propellant-based sprays, which would close the largest remaining gap in the SCCS file on metallic-effect silver.

via cirs-group.com (Original)

Filed under

  • sccs
  • particulate-silver
  • eu-cosmetics-regulation
  • cmr-classification
  • cosmetic-ingredient-safety

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Rebecca Stone

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Staff writer covering industry trends and analytics at INCI File.

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