POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE
What is POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (CAS N/A) in cosmetics and what are its global regulatory limits?
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (CAS No. N/A) is a verified cosmetic ingredient primarily functioning as Emulsifier in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 1–4% within an optimal stability window of pH 4.5–8.5.
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) | POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (KR MFDS Registered) | |
| 2. Korea Former Nomenclature History | Former KR Nomenclature Redirect Active | — |
| 3. European Union (EU CosIng Glossary) | POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE | |
| 4. United States (US PCPC / MoCRA INCI) | POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE | |
| 5. US FDA OTC Monograph Active Name | — (Cosmetic Inactive / Non-OTC) | — |
| 6. China (NMPA IECIC Standard Name) | 聚甘油-3 甲基葡糖二硬脂酸酯 | |
| 7. Japan (JCIA Standard / MHLW Quasi-Drug) | POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (Standard INCI Reference) |
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 #3830 |
| 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 | ≤ 6% | Safe (MoS≥100)NMPA IECIC (2025) Entry 03628 (2025) |
| CN IECIC Historical Max Use | rinse_off | ≤ 5% | Safe (MoS≥100)NMPA IECIC (2025) Entry 03628 (2025) |
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
Layer 3 — Formulation Usage Guide (Quartiles n≥5) & Physicochemical Compatibility
| Formulation Group | Min – Q1 – Median – Q3 – Max (%) | Role & Mechanism | Source ID |
|---|---|---|---|
| Group B — O/W & W/O Emulsion / Lotion / Cream | 1% · 1.8% · 2.5% · 3% · 4% | PEG-free O/W primary lamellar emulsifier | Evonik TEGO Care 450 TDS & Formulation Library (n=195) |
| Group D — Sunscreen (UV) / Color Cosmetics / Foundation | 1% · 1.5% · 2% · 3% · 4% | O/W sunscreen & tone-up cream emulsifier | Evonik TEGO Care 450 Sunscreen Guide |
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.
pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Outside pH 4.5–8.5, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 85°C during standard emulsification.
Cellular & Molecular Target Mechanism Flow
Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)
Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.
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 1 SynthesisSynthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.
Linked Peer-Reviewed Literature (NIH PubMed) (3)
Phytoformulation of Sassurea lappa plant extract: A Single blind, noninvasive and split face study of cream on various skin parameters [PMID: 29105631 · 2017]
Saussurea lappa (SL) has been reported for its antioxidant and anti-ageing properties. Due to this reason it can be incorporated in a stable phytoformulations for cosmetic use. The objective of the study was to evaluate the anti-aging potential of cosmetic o/w emulsion containing the botanical extract of SL. An emulsion (o/w) was prepared using TEGO® Care 450 (Polyglceryl-3-Methyl Glucose Distearate) emulsifier and final emulsion was loaded with 4 % extract of SL in aqueous phase. This emulsion evaluated for its antioxidant and anti-ageing properties on healthy human subjects using a non-invasive technique called surface evaluation of living skin (SELS). The formulation containing SL extract showed significant (p<0.05) changes in Skin roughness (SEr) as -3.13%, -6.26%, -9.39%; Skin Scaliness (SEsc) as - 4.19%, -8.39%, -12.58%; Skin wrinkles (SEw) as -0.5%, -1.08%, -1.63%; and Skin smoothness (SEsm) as 3.28%, 6.57%, 9.85%, respectively, after 30, 60 and 90 days of continous use. Topical application of the cosmetic cream containing SL extract exerts have a significant anti-aging effects, perhaps due to the presence of Kaempferol, gallic acid, Caffeic acid and other essential phenolics.
Influence of processing conditions in the manufacture of O/W creams: II. Effect on drug availability [PMID: 12058808 · 2002]
O/W creams prepared in three mechanical conditions (F with a hand blender; S turbomixer; T vacuum turbo-emulsor) produced different dispersion grades of the internal phase and different rheological characteristics by using surfactants of different chemical nature (polyoxyethylene-cetostearyl alcohols and polyglyceryl-3-methylglucose distearate). Three tests were used (an in vitro release test across a porous membrane; an in vitro simulated absorption test across a porous membrane impregnated with isopropyl myristate; an in vivo absorption test based on the intensity and duration of the erythema produced by methyl nicotinate after application of the cream on the skin) to assess whether the different physical characteristics influence drug availability from the creams. The different physical characteristics due to the mechanical conditions of emulsifying and gelification appeared not to influence drug release and in vivo absorption.
Influence of processing conditions in the manufacture of O/W creams: I. Effect on dispersion grade and rheological characteristics [PMID: 12058807 · 2002]
Two series of O/W creams having the same general formulation were prepared in three different mechanical conditions (F with an hand blender; S with a turbomixer; T with a vacuum turbo emulsor) using two types of surfactants, polyoxyethylene-cetostearyl alcohols and polyglyceryl-3-methylglucose-distearate. By means of microscopic image analysis it was possible to point out the dispersion grade of the oil internal phase increasing with the energy applied under the conditions of manufacture (F < S < T). The level of dispersion influenced significantly on the rheological characteristics of the creams. With polyoxyethylene-cetostearyl alcohols, the viscosity of creams increased as the energy applied in manufacturing increased, with polyglyceryl-3-methylglucose-distearate on the contrary decreased. Moreover, indifferently to the manufacturing conditions, even in the same concentration of surfactant, the creams obtained with the last produced a much greater viscosity. At a parity of manufacturing conditions the differences between the batches of productions were not significant.
Frequently Asked Questions (AEO Position 0)
- Q1. What are the official 7-track regulatory label names for POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE?
- Standard label names are US PCPC INCI: 'POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE', EU CosIng: 'POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE', KR MFDS: 'POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (KR MFDS Registered)', CN NMPA IECIC: '聚甘油-3 甲基葡糖二硬脂酸酯', and JP JCIA: 'POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE'.
- Q2. Is POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE 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 POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE?
- In emulsion_cream systems, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE is typically formulated between 1% and 4% (median 2.5%), with an optimal stability window of pH 4.5–8.5.
- Q4. What are the known formulation incompatibilities and synergy pairings for POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE?
- Recommended synergy pairings include CETEARYL ALCOHOL, GLYCERYL STEARATE, SODIUM STEAROYL GLUTAMATE, CAPRYLIC/CAPRIC TRIGLYCERIDE. Key incompatibilities to avoid: Emulsification below 70°C may lead to incomplete liquid crystal formation and viscosity drift.