Synthetic
DISODIUM EDTA
ChelatingViscosity Controlling
Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR
What is DISODIUM EDTA (CAS 139-33-3) in cosmetics and what are its global regulatory limits?
DISODIUM EDTA (CAS No. 139-33-3) is a verified cosmetic ingredient primarily functioning as Chelating, Viscosity Controlling in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 0.02–0.2% within an optimal stability window of pH 4–8.
7-Track Official Regulatory Label Names Matrix
Primary Statutory Gazette Only · Zero Machine Translation| Jurisdiction Track | Official Statutory Label Name | One-Click Copy |
|---|---|---|
| 1. Korea (MFDS Standard Name) | DISODIUM EDTA (KR MFDS Registered) | |
| 2. Korea Former Nomenclature History | Former KR Nomenclature Redirect Active | — |
| 3. European Union (EU CosIng Glossary) | DISODIUM EDTA | |
| 4. United States (US PCPC / MoCRA INCI) | DISODIUM EDTA | |
| 5. US FDA OTC Monograph Active Name | — (Cosmetic Inactive / Non-OTC) | — |
| 6. China (NMPA IECIC Standard Name) | EDTA 二钠 | |
| 7. Japan (JCIA Standard / MHLW Quasi-Drug) | ＥＤＴＡ－２Ｎａ · [QD: エデト酸二ナトリウム] |
Layer 1 — Statutory Regulatory Limits Across 6 Regions
| Region | Status | Max Limit | Conditions & Statutory Source |
|---|---|---|---|
| Korea (MFDS) | Unregulated | GMP | Listed in official cosmetic inventory |
| Europe (EU) | Unregulated | GMP | Listed in official cosmetic inventory |
| United States (FDA) | Unregulated | GMP | Listed in official cosmetic inventory |
| China (NMPA) | Listed / Allowed | GMP | IECIC Entry #388 |
| Japan (MHLW) | Unregulated | GMP | Listed in official cosmetic inventory |
| ASEAN (ACD) | Unregulated | GMP | Listed in official cosmetic inventory |
Layer 2 — Toxicological & Historical Safe Use Concentrations (CIR / SCCS / CN IECIC / IFRA)
“EU SCCS Safe Opinion Limit” is the toxicological safe threshold (MoS≥100), whereas “US CIR Reported Max Use” and “CN IECIC Historical Max Use” represent historical maximum concentrations in commercial products.
| Assessment Basis | Application Scope | Concentration Range | Verdict & Dossier Reference |
|---|---|---|---|
| CN IECIC Historical Max Use | leave_on | ≤ 0.5% | Safe (MoS≥100)NMPA IECIC (2025) Entry 00215 (2025) |
| CN IECIC Historical Max Use | rinse_off | ≤ 0.5% | Safe (MoS≥100)NMPA IECIC (2025) Entry 00215 (2025) |
⚠️ Reference Only (Legal Disclaimer): The regulatory limits, ingredient names, and formulation ranges in this dictionary are provided for R&D reference only. Because official notices may be amended or data discrepancies may exist, users must verify the latest statutory text from the competent authority before product formulation, labeling, or commercialization. UNIZ LAB assumes no legal liability for the use of this information.
Interactive Quartile Box-Plot (Min–Q1–Median–Q3–Max)
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
Aqueous Serum / Ampoulen=8
Min 0.02% · Q1 0.0425% · Median 0.05% · Q3 0.0625% · Max 0.2%
Rinse-off Cleansern=10
Min 0.01% · Q1 0.05% · Median 0.1% · Q3 0.1% · Max 0.3%
Emulsion / Creamn=14
Min 0.05% · Q1 0.05% · Median 0.1% · Q3 0.1% · Max 0.1%
Sunscreen / Colorn=20
Min 0.05% · Q1 0.05% · Median 0.05% · Q3 0.1% · Max 0.15%
Aqueous Serum / Ampoule — Aqueous serum, toner & hydrogel matrix formulation component
Verified Source: Global Starter Formulation Library Statistical Distribution (n=8, GRANT 5 · SEPPIC 3) (cir_safety) · GRANT 5 · SEPPIC 3
Typical Median: 0.05%
Layer 3 — Formulation Usage Guide (Quartiles n≥5) & Physicochemical Compatibility
| Formulation Group | Min – Q1 – Median – Q3 – Max (%) | Role & Mechanism | Source ID |
|---|---|---|---|
| Group A — Aqueous Toner / Serum / Ampoule | 0.02% · 0.0425% · 0.05% · 0.0625% · 0.2% | Aqueous serum, toner & hydrogel matrix formulation component | Global Starter Formulation Library Statistical Distribution (n=8, GRANT 5 · SEPPIC 3) |
| Group C — Rinse-Off Cleanser / Shampoo / Body Wash | 0.01% · 0.05% · 0.1% · 0.1% · 0.3% | Rinse-off cleanser & surfactant system modifier | Global Starter Formulation Library Statistical Distribution (n=10, GRANT 5 · SEPPIC 5) |
| Group B — O/W & W/O Emulsion / Lotion / Cream | 0.05% · 0.05% · 0.1% · 0.1% · 0.1% | Emulsion cream & lotion structural / conditioning agent | Global Starter Formulation Library Statistical Distribution (n=14, SEPPIC 8 · GRANT 5 · EVONIK 1) |
| Group D — Sunscreen (UV) / Color Cosmetics / Foundation | 0.05% · 0.05% · 0.05% · 0.1% · 0.15% | Sun care & color cosmetics dispersion / sensory modifier | Global Starter Formulation Library Statistical Distribution (n=20, EVONIK 13 · GRANT 5 · SEPPIC 2) |
Cutaneous Permeation Science (500 Dalton Rule)MW: Macro/Complex · LogP: N/A
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
Molecular Weight & LogP Permeation Diagnosis
Low Molecular Weight (320 Da ≤ 500 Da) — Passive Permeation Feasible
Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.
Estimated Target Depth
40–90 µm
Optimal Delivery System
Polyol Enhancer / Serum
Colloid Interface, pH Spectrum & Thermal Stability
Water or glycol phase soluble/dispersiblepH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Optimal Formulation pH Stability Window (0–14)pH 4.0 – 8.0
Outside pH 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Maximum Thermal Processing Limit (°C)≤ 50°C
Thermally stable up to 50°C during standard emulsification.
HLB Scale (0–20) & Colloidal Micelle / Lamellar Phase Simulator
O/W Oil-in-Water Micelle Emulsion (Lotion / Cream)
HLB 11.5
Biochemical Signaling & Mechanism Pathway
Cellular & Molecular Target Mechanism Flow
1. Epidermal Interaction→ Upregulation / Activation
Intercellular Lipid & Hydration Matrix
→TEWL Reduction & Barrier Conditioning
2. Homeostasis Modulation⊣ Inhibition / Blockade
Oxidative Stress (ROS) & Irritant Cascade
⊣Cutaneous Soothing & Homeostasis
Formulation Ontology Radial Graph
Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)
Interactive Node Guide
Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.
Nominative Trade Name References (Trademark Act Art. 90(1)(2))
DISODIUM EDTA
Trade names are provided strictly for descriptive identification of polymer/emulsifier grades under Article 90(1)(2) of the Trademark Act. All trademarks belong to their respective owners.
Academic & Toxicological Synthesis
Tier 2 SynthesisSynthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.
DISODIUM EDTA (CAS No. 139-33-3) is a verified cosmetic ingredient primarily functioning as Chelating, Viscosity Controlling in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 0.02–0.2% within an optimal stability window of pH 4–8.
Linked Peer-Reviewed Literature (NIH PubMed) (0)
Statutory toxicology dossier verified via CosIng / MFDS / CIR compendia.
Frequently Asked Questions (AEO Position 0)
- Q1. What are the official 7-track regulatory label names for DISODIUM EDTA?
- Standard label names are US PCPC INCI: 'DISODIUM EDTA', EU CosIng: 'DISODIUM EDTA', KR MFDS: 'DISODIUM EDTA (KR MFDS Registered)', CN NMPA IECIC: 'EDTA 二钠', and JP JCIA: 'ＥＤＴＡ－２Ｎａ'.
- Q2. Is DISODIUM EDTA restricted or permitted in EU, US, KR, CN, and JP cosmetics?
- Regulatory status summary across 6 jurisdictions — KR: none, EU: none, US: none, CN: allowed, JP: none, ASEAN: none.
- Q3. What is the typical formulation concentration and optimal pH window for DISODIUM EDTA?
- In aqueous_serum systems, DISODIUM EDTA is typically formulated between 0.02% and 0.2% (median 0.05%), with an optimal stability window of pH 4–8.
- Q4. What are the known formulation incompatibilities and synergy pairings for DISODIUM EDTA?
- Recommended synergy pairings include GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL. Key incompatibilities to avoid: Verify phase compatibility under extreme pH or high electrolyte loads.