Ingredient Dictionary/polyglyceryl-3-methylglucose-distearate/POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE
Tier 1 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
Synthetic

POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE

Emulsifier
[EU CosIng Official Definition] Methyl-D-glucopyranoside, ethers with 1,2,3-propanetriol homopolymer, octadecanoates (1:1:2) (3 mol glycerol average molar ratio)
Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR

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
7-Track Official Statutory Label Names for POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE
Jurisdiction TrackOfficial Statutory Label NameOne-Click Copy
1. Korea (MFDS Standard Name)POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (KR MFDS Registered)
2. Korea Former Nomenclature HistoryFormer 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

Layer 1 Statutory Regulatory Limits Across 6 Regions for POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE
RegionStatusMax LimitConditions & Statutory Source
Korea (MFDS)UnregulatedGMPListed in official cosmetic inventory
Europe (EU)UnregulatedGMPListed in official cosmetic inventory
United States (FDA)UnregulatedGMPListed in official cosmetic inventory
China (NMPA)Listed / AllowedGMPIECIC Entry #3830
Japan (MHLW)UnregulatedGMPListed in official cosmetic inventory
ASEAN (ACD)UnregulatedGMPListed 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.

Layer 2 Toxicological & Historical Safe Use Concentrations for POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE
Assessment BasisApplication ScopeConcentration RangeVerdict & Dossier Reference
CN IECIC Historical Max Useleave_on≤ 6%Safe (MoS≥100)NMPA IECIC (2025) Entry 03628 (2025)
CN IECIC Historical Max Userinse_off≤ 5%Safe (MoS≥100)NMPA IECIC (2025) Entry 03628 (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

Emulsion / Creamn=195
Min 1% · Q1 1.8% · Median 2.5% · Q3 3% · Max 4%
Sunscreen / Colorn=48
Min 1% · Q1 1.5% · Median 2% · Q3 3% · Max 4%
Emulsion / Cream — PEG-free O/W primary lamellar emulsifier
Verified Source: Evonik TEGO Care 450 TDS & Formulation Library (n=195) (cir_safety) · Evonik 178 · SEPPIC 17
Typical Median: 2.5%

Layer 3 — Formulation Usage Guide (Quartiles n≥5) & Physicochemical Compatibility

Layer 3 Formulation Concentration Quartiles by Product Category for POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE
Formulation GroupMin – Q1 – Median – Q3 – Max (%)Role & MechanismSource ID
Group B — O/W & W/O Emulsion / Lotion / Cream1% · 1.8% · 2.5% · 3% · 4%PEG-free O/W primary lamellar emulsifierEvonik TEGO Care 450 TDS & Formulation Library (n=195)
Group D — Sunscreen (UV) / Color Cosmetics / Foundation1% · 1.5% · 2% · 3% · 4%O/W sunscreen & tone-up cream emulsifierEvonik TEGO Care 450 Sunscreen Guide
Cutaneous Permeation Science (500 Dalton Rule)MW: Macro/Complex · LogP: N/A

Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery

Stratum Corneum (Brick & Mortar Barrier · 10–20 µm)500 Da Molecular Weight Cutoff BarrierViable Epidermis (Keratinocytes & Melanocytes · 50–100 µm)Target for Brightening (Tyrosinase/Melanosome) & Barrier LipidsPapillary Dermis (Fibroblasts & ECM Collagen · 150–300 µm)Target for Collagen I/III Synthesis, Peptides, PDRN & ExosomesEpidermal Passive Permeation (<500 Da)
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

pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior

Oil soluble (melts at ~55~60°C)
Optimal Formulation pH Stability Window (0–14)pH 4.5 – 8.5
0245.5791114

Outside pH 4.5–8.5, risk of hydrolysis, viscosity loss, or ionic dissociation increases.

Maximum Thermal Processing Limit (°C)≤ 85°C
25°C45°C60°C75°C85°C100°C

Thermally stable up to 85°C during standard emulsification.

HLB Scale (0–20) & Colloidal Micelle / Lamellar Phase Simulator
O/W Oil-in-Water Micelle Emulsion (Lotion / Cream)
HLB 12.0
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)O/W Droplet
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)

+ CETEARYL ALCOHOL+ GLYCERYL STEARATE+ SODIUM STEAROYL GL…+ CAPRYLIC/CAPRIC TR…✕ Emulsification below…POLYGLYCERYL-3 MET…
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))
TEGO® Care 450

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 Synthesis

Synthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.

■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE | CAS No.: N/A | EC No.: N/A - Origin: SYNTHETIC | Functions: - Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS - Official Regional Label Names: US [POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE] · EU [POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE] · CN [聚甘油-3 甲基葡糖二硬脂酸酯] · JP [-] · JP Quasi-Drug [-] ■ [2. Dermatological Mechanism of Action & Functional Role] - Methyl-D-glucopyranoside, ethers with 1,2,3-propanetriol homopolymer, octadecanoates (1:1:2) (3 mol glycerol average molar ratio) Classified under origin 'synthetic', it acts within the cosmetic vehicle or stratum corneum to deliver performance and structural formulation stability. ■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)] - Regional Summary: KR: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 3830 (聚甘油-3 甲基葡糖二硬脂酸酯)) - No specific Annex prohibition or numeric restriction across the 6 major jurisdictions (Permitted under general GMP safety assessment). - Official Safety & Historical Use Concentration (Layer 2): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 6.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 5.0% ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [emulsion_cream] Typical range: 1.0 ~ 4.0% (Median 2.5%, Ref: Evonik TEGO Care 450 TDS & Formulation Library (n=195)) — PEG-free O/W primary lamellar emulsifier - [sun_color] Typical range: 1.0 ~ 4.0% (Median 2.0%, Ref: Evonik TEGO Care 450 Sunscreen Guide) — O/W sunscreen & tone-up cream emulsifier ■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)] - Addition Phase: Oil Phase (Heat to 75~80°C) - Optimal pH Range: pH 4.5 ~ 8.5 | Max Process Temp: Max 85°C | Electrolyte Tolerance: HIGH - Incompatibility / Caution: Emulsification below 70°C may lead to incomplete liquid crystal formation and viscosity drift - Synergy Pairings: CETEARYL ALCOHOL, GLYCERYL STEARATE, SODIUM STEAROYL GLUTAMATE, CAPRYLIC/CAPRIC TRIGLYCERIDE | Reference Trade Names: TEGO® Care 450 ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 29105631 (2017, Pak J Pharm Sci): Phytoformulation of Sassurea lappa plant extract: A Single blind, noninvasive and split face study of cream on various s - PMID 12058808 (2002, Farmaco): Influence of processing conditions in the manufacture of O/W creams: II. Effect on drug availability - PMID 12058807 (2002, Farmaco): Influence of processing conditions in the manufacture of O/W creams: I. Effect on dispersion grade and rheological chara

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]
Adnan Q, Akhtar N, Khan BA · Pak J Pharm Sci (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&#xae; 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&lt;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]
Realdon N, Ragazzi E, Morpurgo M, Ragazzi E · Farmaco (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]
Realdon N, Perin F, Morpurgo M, Ragazzi E · Farmaco (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 &lt; S &lt; 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.