Poor Active Ingredient NOAEL Data GHS Classified SCCS/CIR Reviewed

Silver

Also known as: Amalgum, Caswell No. 735, EINECS 231-131-3, EPA Pesticide Chemical Code 072501, Germany: C-Pigment 2 (+12 more)

INCI: SILVER

Silver (CAS 7440-22-4) is a cosmetic active ingredient functioning as Antimicrobial; preservative co-active; antifungal; anti-biofilm. NOAEL 0.0045 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: prohibited, max 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%); GHS signal word WARNING. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial

View industrial chemical safety profile for CAS 7440-22-4 →

Auto-generated CPSR Part A draft with source citations
CAS Number
7440-22-4
View industrial chemical safety profile →
Function
Antimicrobial; preservative co-active; antifungal; anti-biofilm
Safety Rating
POOR

Chemistry & Identifiers

EC Number
231-131-3
ChEBI: CHEBI:9141 UNII: 3M4G523W1G Wikidata: Q1090

Regulatory Status

EU 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 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 multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Silver.

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 =0.00056 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).

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

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for 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
Biocide Catalyst Deodorizer Dye Plating agent Softener and conditioner Surface modifier
Regulatory List Membership (2)
EU Regulated in Personal Care EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Silver.

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

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Silver by CAS number or substance name.

Studies
107
Lowest NOAEL
0.00056
Highest NOAEL
1000

Units vary across source rows: mg/kg bw/day, mg/kg bw/d, mg/kg

ToxValDB_ECHA_IUCLID SCCS_vision_codex ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip

Dermal Absorption

View details ->
Absorption % Method Vehicle
1.76 method=default; type=in_vitro -
1.0 method=measured -
4.0 method=measured -
5.0 method=measured; type=in_vitro -
1.76 method=default -

Known Synonyms

Amalgum Caswell No. 735 EINECS 231-131-3 EPA Pesticide Chemical Code 072501 Germany: C-Pigment 2 Silver, colloidal Silver Granufoam UNII-3M4G523W1G Argentum metallicum Ag(0) Agn silver(0) 47Ag Ag Silber argent plata

Chemical Function

Dye Biocide Deodorizer Softener and conditioner Surface modifier Catalyst

Regulatory Lists

Arts and crafts/Office supplies - body paint - tattoo ink; detected; Europe Arts and crafts/Office supplies - body paint - tattoo ink; detected; Europe Arts and crafts/Office supplies - body paint - tattoo ink; detected; Europe Arts and crafts/Office supplies - body paint - tattoo ink; detected; Europe Arts and crafts/Office supplies - body paint - tattoo ink; detected; Europe Arts and crafts/Office supplies - body paint - tattoo ink; detected; Europe Arts and crafts/Office supplies - body paint - tattoo ink; detected; Europe active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in pharmaceutical data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA count match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

Adverse Event Associations
16
View full pharmaceutical profile →

Frequently Asked Questions

Is Silver safe in cosmetics?

Silver has a safety rating of "POOR" in our database. EU status: prohibited. US status: permitted. 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 NOAEL for Silver?

The NOAEL (No Observed Adverse Effect Level) for 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 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.

Is Silver used outside cosmetics?

Silver also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Does Silver have different safety status in cosmetics vs industrial chemicals?

Silver is prohibited in EU cosmetics at max 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%) but has active industrial GHS classifications (H400, H410).

Compliance Tools

Check Silver compliance across multiple jurisdictions:

Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions

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