Poor Active Ingredient NOAEL Data GHS Classified SCCS/CIR Reviewed

Silver

INCI: SILVER

CAS Number
7440-22-4
Function
Antimicrobial; preservative co-active; antifungal; anti-biofilm
Safety Rating
POOR

Regulatory Status

🇪🇺 EU Status prohibited
EU Max Conc. Nano silver (1–100 nm): fully banned from Feb 1 2025. Non-nano silver (100 nm–1 mm): restricted from May 1 2026 to toothpaste (≤0.05%), mouthwash (≤0.05%), eye shadow (≤0.2%), lip products (≤0.2%)
🇺🇸 US Status permitted
US Notes No specific FDA cosmetic ban on colloidal or nano silver as of 2025–2026, but FDA has warned against antibacterial silver product claims. Silver in oral care and topical products remains in legal grey zone with no GRAS classification. Aquatic toxicity and antimicrobial resistance concerns are monitored.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
high
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Silver. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.

Endpoint Value Route Species Study Type Source
NOAEL 0.0045 mg/kg bw/day - - - SCCS_PDF_extraction
NOAEL 0.0045 mg/kg bw/day oral - - SCCS_PDF_extraction
NOAEL 300 mg/kg bw/day oral - subacute SCCS_PDF_extraction
NOAEL 125 mg/kg bw/day oral - subchronic SCCS_PDF_extraction
NOAEL 0.25 mg/kg bw/day - - reproductive SCCS_PDF_extraction
NOAEL 0.0045 mg/kg bw/day - mouse chronic SCCS_PDF_extraction
NOAEL 250 mg/kg bw/day oral - subchronic SCCS_PDF_extraction
NOAEL 1000 mg/kg bw/day oral - subchronic SCCS_PDF_extraction
NOAEL 1000 mg/kg bw/day - - reproductive SCCS_PDF_extraction
NOAEL 0.0045 mg/kg bw/day - - - SCCS_PDF_extraction

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Signal Word
WARNING
Pictograms
enviro;aqua
Hazard Statements
Very toxic to aquatic life with long lasting effects
Short-term Exposure Effects
May cause mechanical irritation to the eyes and respiratory tract.
Long-term Exposure Effects
The substance may cause a grey-blue discolouration of the eyes, nose, throat and skin (argyria/argyrosis).
Routes of Exposure
The substance can be absorbed into the body by inhalation and by ingestion.

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

sccs SCCS/1665/24 20 June 2024
Verdict: not safe
NOAEL: 0.0045 mg/kg bw/d (not specified)
Max Concentration: 0.2% in leave-on

classification as toxic for reproduction Cat. 2, the SCCS considers micron-sized particulate Silver not safe at concentrations up to 0.2 % in rinse-off and 0.3 % in leave-on cosmetic products when used alone or in combination. However, the use of micron-sized particulate Silver in eye shadow and oral

sccs SCCS/1665/24 20 June 2024
Verdict: not safe
NOAEL: 0.0045 mg/kg bw/d (not specified)
Max Concentration: 0.3% in leave-on

classification as toxic for reproduction Cat. 2, the SCCS considers micron-sized particulate Silver not safe at concentrations up to 0.2 % in rinse-off and 0.3 % in leave-on cosmetic products when used alone or in combination. However, the use of micron-sized particulate Silver in eye shadow and oral

sccs SCCS/1665/24 20 June 2024
Verdict: not safe
NOAEL: 0.0045 mg/kg bw/d (oral)
Max Concentration: 0.2% in leave-on

classification as toxic for reproduction Cat. 2, the SCCS considers micron-sized particulate Silver not safe at concentrations up to 0.2 % in rinse-off and 0.3 % in leave-on cosmetic products when used alone or in combination. However, the use of micron-sized particulate Silver in eye shadow and oral

sccs SCCS/1665/24 20 June 2024
Verdict: not safe
NOAEL: 0.0045 mg/kg bw/d (oral)
Max Concentration: 0.3% in leave-on

classification as toxic for reproduction Cat. 2, the SCCS considers micron-sized particulate Silver not safe at concentrations up to 0.2 % in rinse-off and 0.3 % in leave-on cosmetic products when used alone or in combination. However, the use of micron-sized particulate Silver in eye shadow and oral

sccs SCCS/1687/25 17 December 2025
Verdict: unknown
NOAEL: 0.0045 mg/kg bw/d (not specified)
Max Concentration: 0.2% in leave-on

Expert Verdict

Nano silver fully banned from EU cosmetics effective Feb 1 2025 (Reg 2024/858) with market withdrawal deadline Nov 1 2025. Non-nano silver restricted from May 1 2026 to toothpaste, mouthwash, eye shadow, and lip products at specified concentrations. SCCS found micron-sized silver unsafe at higher concentrations in most cosmetics due to argyria risk (irreversible silver tissue deposition), aquatic ecotoxicity from ionic silver release, and antimicrobial resistance implications. US market lacks specific ban but FDA signaled concern. Reformulate affected EU products immediately using alternatives such as zinc PCA, copper peptides, or established preservative systems.

⚠️
Concern Level: High

Regulatory Flags

eu-banned-nano eu-restricted-non-nano reg-2024-858 argyria-risk aquatic-toxic antimicrobial-resistance-concern reformulate-required-eu regulatory-action-required nano-banned eu_cosing_listed

Frequently Asked Questions

Is Silver safe in cosmetics?

Nano silver fully banned from EU cosmetics effective Feb 1 2025 (Reg 2024/858) with market withdrawal deadline Nov 1 2025. Non-nano silver restricted from May 1 2026 to toothpaste, mouthwash, eye shadow, and lip products at specified concentrations. SCCS found micron-sized silver unsafe at higher concentrations in most cosmetics due to argyria risk (irreversible silver tissue deposition), aquatic ecotoxicity from ionic silver release, and antimicrobial resistance implications. US market lacks specific ban but FDA signaled concern. Reformulate affected EU products immediately using alternatives such as zinc PCA, copper peptides, or established preservative systems. The EU classifies Silver as "prohibited". Safety rating: POOR. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.

Is Silver allowed in the EU?

Silver EU regulatory status: prohibited. Maximum allowed concentration: Nano silver (1–100 nm): fully banned from Feb 1 2025. Non-nano silver (100 nm–1 mm): restricted from May 1 2026 to toothpaste (≤0.05%), mouthwash (≤0.05%), eye shadow (≤0.2%), lip products (≤0.2%). This is based on EU Regulation 1223/2009 and its amendments.

What does Silver do in cosmetics?

Silver functions as: Antimicrobial; preservative co-active; antifungal; anti-biofilm. It is classified as a Active Ingredient in our database. CAS number: 7440-22-4.

What is the Margin of Safety for Silver?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for Silver?

The NOAEL (No Observed Adverse Effect Level) for Silver is 0.0045 mg/kg bw/day based on a toxicological study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS_PDF_extraction.

Is Silver classified as hazardous under GHS?

Silver carries a GHS signal word of "WARNING". Hazard statements: Very toxic to aquatic life with long lasting effects. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.

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