Poor Active Ingredient NOAEL Data GHS Classified SCCS/CIR Reviewed

Colloidal Silver

INCI: SILVER (NANO)

CAS Number
7440-22-4
Function
Antimicrobial; preservative; used historically in deodorants, anti-acne products, and preservation systems due to broad-spectrum antibacterial activity
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
EU Max Conc. Nano silver particles prohibited under EU Omnibus VIII (Regulation EU 2024/2564); compliance deadline 1 May 2026
๐Ÿ‡บ๐Ÿ‡ธ US Status prohibited
US Notes FDA 1999 final rule: OTC colloidal silver products are not generally recognized as safe and effective (not GRASE) for any condition. Products marketed with health/wound-healing claims are considered misbranded drugs. No approved cosmetic or OTC drug status.

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 Colloidal 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

Colloidal silver (nano silver particles) is prohibited in EU cosmetics under Omnibus VIII (Regulation EU 2024/2564) with compliance deadline 1 May 2026, and is not GRASE-approved by the FDA. Silver nanoparticles penetrate skin, enter systemic circulation, bioaccumulate in aquatic environments, and cause cytotoxicity in vitro. Do not formulate for cosmetic applications.

โš ๏ธ
Concern Level: High

Regulatory Flags

eu-prohibited-2026 fda-not-grase cytotoxic impairs-healing nano-form do-not-formulate regulatory-high-risk eu_cosing_listed

Frequently Asked Questions

Is Colloidal Silver safe in cosmetics?

Colloidal silver (nano silver particles) is prohibited in EU cosmetics under Omnibus VIII (Regulation EU 2024/2564) with compliance deadline 1 May 2026, and is not GRASE-approved by the FDA. Silver nanoparticles penetrate skin, enter systemic circulation, bioaccumulate in aquatic environments, and cause cytotoxicity in vitro. Do not formulate for cosmetic applications. The EU classifies Colloidal Silver as "prohibited". Safety rating: POOR. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.

Is Colloidal Silver allowed in the EU?

Colloidal Silver EU regulatory status: prohibited. Maximum allowed concentration: Nano silver particles prohibited under EU Omnibus VIII (Regulation EU 2024/2564); compliance deadline 1 May 2026. This is based on EU Regulation 1223/2009 and its amendments.

What does Colloidal Silver do in cosmetics?

Colloidal Silver functions as: Antimicrobial; preservative; used historically in deodorants, anti-acne products, and preservation systems due to broad-spectrum antibacterial activity. It is classified as a Active Ingredient in our database. CAS number: 7440-22-4.

What is the Margin of Safety for Colloidal 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 Colloidal Silver?

The NOAEL (No Observed Adverse Effect Level) for Colloidal 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 Colloidal Silver classified as hazardous under GHS?

Colloidal 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 โ€” at cosmetic use concentrations, hazard thresholds may not be met.

๐Ÿ“ฑ

Is Colloidal Silver in Your Products?

Scan any product label with Piro โ€” our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free โ†’

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Colloidal Silver in your formulation.