Also known as: Amalgum, Caswell No. 735, EINECS 231-131-3, EPA Pesticide Chemical Code 072501, Germany: C-Pigment 2 (+12 more)
INCI: SILVER (NANO)
Colloidal Silver (CAS 7440-22-4) is a cosmetic active ingredient functioning as Antimicrobial; preservative; used historically in deodorants, anti-acne. NOAEL 0.0045 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: prohibited, max Nano silver particles prohibited under EU Omnibus VIII (Regulation EU 2024/2564); compliance deadline 1 May 2026; GHS signal word WARNING. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and food safety data.
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Colloidal Silver is prohibited in EU cosmetics at max Nano silver particles prohibited under EU Omnibus VIII (Regulation EU 2024/2564); compliance deadline 1 May 2026 but has active industrial GHS classifications (H400, H410).
Antimicrobial; preservative; used historically in deodorants, anti-acne products, and preservation systems due to broad-spectrum antibacterial activity
EU Max Conc.Nano silver particles prohibited under EU Omnibus VIII (Regulation EU 2024/2564); compliance deadline 1 May 2026
US US Statusprohibited
US NotesFDA 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 multiple jurisdictions, use the
Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Colloidal Silver.
Calculate MoS for your specific formulation with the
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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
=0.00056 mg/kg bw/d
oral
human
NOAEL study
SCCS_vision_codex
NOAEL
=0.00056 mg/kg bw/d
oral
human
NOAEL study
SCCS_vision_codex
NOAEL
=0.00056 mg/kg bw/d
oral
human
NOAEL study
SCCS_vision_codex
NOAEL
=0.00056 mg/kg bw/d
oral
human
NOAEL study
SCCS_vision_codex
NOAEL
=0.0045 mg/kg bw/d
oral
rat
repeated dose toxicity
SCCS_vision_codex
NOAEL
=0.0045 mg/kg bw/d
oral
rat
repeated dose toxicity
SCCS_vision_codex
NOAEL
=0.0045 mg/kg bw/d
oral
rat
repeated dose toxicity
SCCS_vision_codex
NOAEL
=0.0045 mg/kg bw/d
oral
rat
repeated dose toxicity
SCCS_vision_codex
NOAEL
=0.0045 mg/kg bw/d
oral
rat
repeated dose toxicity
SCCS_vision_codex
NOAEL
=0.0045 mg/kg bw/d
oral
rat
repeated dose toxicity
SCCS_vision_codex
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Signal Word
WARNING
Pictograms
EnviroAqua
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).
sccsSCCS/1665/2420 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
sccsSCCS/1665/2420 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
sccsSCCS/1665/2420 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
sccsSCCS/1665/2420 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
sccsSCCS/1687/2517 December 2025
Verdict: unknown
NOAEL: 0.0045 mg/kg bw/d (not specified)
Max Concentration: 0.2% in leave-on
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Colloidal Silver across SCCS product categories, with measured dermal absorption where available.
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Warning
Pictograms
Health Hazard
Hazard Class and Category
Repr. 2; STOT RE 2
Hazard Statements
H361f
H373 (nervous system)
Inserted via ATP: ATP22
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10,000 - 100,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification:Restricted (Annex XVII)
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 1727
(EU) 2026/78
Annex IV — Permitted Colorants
Product type: White
Max: (a) Lip products
(b) Eye shadow
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
Additional Jurisdictional Restrictions (5)
Jurisdiction
Status
Max %
Product Type
CN
permitted_colorant
-
All cosmetics (Class 1)
BR
permitted_colorant
-
Column 3: Not near mucous membranes
UK
restricted
-
-
CA
restricted
0.04% (mouthwash only)
Mouthwash only
ASEAN
permitted_colorant
-
All products
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (5 records across 5 sources)
Type
DA %
Method
Skin Model
SCCS Ref
default
1.76
method=default; type=in_vitro
-
-
measured
1.0
method=measured
-
-
measured
4.0
method=measured
-
-
measured
5.0
method=measured; type=in_vitro
-
-
default
1.76
method=default
-
-
Function Categories & List Membership
Cosmetic/Chemical Function Categories
BiocideCatalystDeodorizerDyePlating agentSoftener and conditionerSurface modifier
Regulatory List Membership (2)
EU Regulated in Personal CareEU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Colloidal Silver.
Colloidal Silver has a safety rating of "POOR" in our database. EU status: prohibited. US status: prohibited. 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 NOAEL for Colloidal Silver?
The NOAEL (No Observed Adverse Effect Level) for Colloidal Silver is =0.00056 mg/kg bw/d based on a NOAEL study study via oral route in human. A total of 10 study endpoints are available. Source: SCCS_vision_codex.
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 — at cosmetic use concentrations, hazard thresholds may not be met.
Is Colloidal Silver used outside cosmetics?
Colloidal Silver also appears in industrial chemical safety and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Colloidal Silver have different safety status in cosmetics vs industrial chemicals?
Colloidal Silver is prohibited in EU cosmetics at max Nano silver particles prohibited under EU Omnibus VIII (Regulation EU 2024/2564); compliance deadline 1 May 2026 but has active industrial GHS classifications (H400, H410).
Compliance Tools
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