LECITHIN
What is LECITHIN (CAS 8002-43-5) in cosmetics and what are its global regulatory limits?
LECITHIN (CAS No. 8002-43-5) is a verified cosmetic ingredient primarily functioning as Antistatic, Skin Conditioning, Emollient in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 0.05–5% 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) | LECITHIN (KR MFDS Registered) | |
| 2. Korea Former Nomenclature History | — | — |
| 3. European Union (EU CosIng Glossary) | LECITHIN | |
| 4. United States (US PCPC / MoCRA INCI) | LECITHIN | |
| 5. US FDA OTC Monograph Active Name | — (Cosmetic Inactive / Non-OTC) | — |
| 6. China (NMPA IECIC Standard Name) | 卵磷脂 | |
| 7. Japan (JCIA Standard / MHLW Quasi-Drug) | LECITHIN (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 #4456 |
| Japan (MHLW) | Unregulated | GMP | Listed in official cosmetic inventory |
| ASEAN (ACD) | Unregulated | GMP | Listed in official cosmetic inventory |
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 | 0.05% · 0.1625% · 0.75% · 1.5% · 5% | Emulsion cream & lotion structural / conditioning agent | Global Starter Formulation Library Statistical Distribution (n=10, GRANT 9 · ELEMENTIS 1) |
| Group D — Sunscreen (UV) / Color Cosmetics / Foundation | 0.3% · 0.8% · 1% · 1% · 1.5% | Sun care & color cosmetics dispersion / sensory modifier | Global Starter Formulation Library Statistical Distribution (n=25, GRANT 25) |
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 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 50°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) (12)
Shake-Induced Temporary Ion-Pairing Between Lecithin and Glycolic Acid for Enhanced Exfoliation in a Novel Biphasic Serum: Comparative Ex Vivo and in Vivo Randomised Studies [PMID: 41987370 · 2026]
Chemical exfoliation efficacy is significantly limited by pH-dependent permeability reduction above the pKa of glycolic acid (3.83), constraining consumer product development. To develop and evaluate a biphasic serum utilizing temporary lecithin-glycolate ion-pairing to enhance stratum corneum permeation while maintaining safety at pH 3.9. A biphasic formulation containing 10 wt% (weight percent) glycolic acid and 0.1 wt% lecithin was developed. Temporary ion-pairing was characterized by FT-IR spectroscopy. Ex vivo permeation and exfoliation were evaluated using porcine skin models. A 2-week double-blind, split-face clinical study (n = 37) assessed efficacy using instrumental probes (Visioscan, Corneofix, VISIA-CR, and ANTERA 3D) for exfoliation-related parameters and sensitive skin compatibility. FT-IR analysis confirmed lecithin-glycolate bonding via red-shifted C = O peaks, with spectral comparisons before and after shaking demonstrating the reversible nature of the change. The biphasic serum achieved 4.19-fold higher epidermal glycolic acid delivery compared to conventional formulations with minimal deep penetration. Clinical evaluation demonstrated superior exfoliation (45.52% improvement, p < 0.001), enhanced skin brightness, texture, and hydration. Redness and transepidermal water loss, assessed for sensitive skin suitability, showed significant improvements. The biphasic system successfully overcomes pH-dependent limitations of glycolic acid through temporary ion-pairing, providing enhanced exfoliation efficacy with a superior safety profile for consumer applications.
Unravelling the mechanisms behind the stabilization of oil foams using soybean lecithin [PMID: 42013529 · 2026]
Oil foams are emerging as a promising, versatile system in food, cosmetic and pharmaceutical applications. Existing solutions depend on the addition of particles or surfactant crystallization; however, these approaches often require complex processing steps, introduce solid residues that may affect texture, and rely on kinetically trapped interfacial structures that limit reversibility under ambient conditions. Here, we examine the foamability and stability of food-grade, soybean lecithin in oil of different surface tension. We found that edible oil foams can be formed at room temperature only in long-chain triglyceride oils. By combining microscopy, X-ray techniques, and interfacial rheology, we show that the stabilization arises from the formation of inverse lipid bilayers at the air-oil surface, leading to increased surface elastic modulus and dense thin-films that protect the gas bubbles. We also discovered that different self-assembled structures are formed in different oils. These findings uncover a molecular mechanism for non-aqueous foam stabilization under ambient conditions and establish design principles for surfactant-stabilized oil foams, without particle additives or crystallization.
Recycling of hazelnut waste: Antidiabetic properties of soy lecithin nanoparticles and their in vitro anti-proliferative effects in tumor cell lines [PMID: 41913074 · 2026]
Hazelnuts and foods produced using hazelnuts are consumed with pleasure, but it is important to evaluate the waste generated during hazelnut processing and determine their usage methods. This study was conducted to determine the changes in bioactive components, bioaccessibility and antidiabetic activity of nanoparticles synthesized using soy lecithin from hazelnut wastes. The shell-derived nanoparticles had the highest zeta potential (-38.62 mV), and the smallest particle size and polydispersity index values. The production efficiency of nanoparticles was in the range of 79.10-89.46%, and the loading capacity was in the range of 38.17-52.59%. The antioxidant properties and thermal stability of the shell nanoparticle were higher. The highest gallic acid, rutin, o-coumaric acid, quercetin and kaempferol were measured in shell nanoparticles. In the bioaccessibility results, gallic acid (69.47%), protocatechuic acid (61.28%), quercetin (61.50%) and kaempferol (52.07%) were at the highest values in the shell nanoparticle. Lipid peroxidation inhibition was highest in shell nanoparticles (8.41 mg mL -1 ), while the lowest effect was measured in husk nanoparticles. The order of antidiabetic activity was shell nanoparticles > skin nanoparticles > husk nanoparticles. The investigation revealed that the nanoparticles exhibited significant anticancer activity in the MCF-7 breast cancer and HT-29 colon cancer cell lines. Principal component analysis showed that antioxidant properties are the key drivers of principal component one (PC1), while enzyme activities influence principal component two (PC2). The results obtained revealed the potential use of nanoparticles produced from hazelnut waste (especially shell) for therapeutic purposes and prevention of diseases associated with oxidative stress. © 2026 The Author(s). Journal of the Science of Food and Agriculture published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.
Retinol-Loaded Mannosylerythritol Lipid Nanoliposome for Enhanced Human Skin Penetration [PMID: 42246630 · 2026]
Functional cosmetic materials with anti-aging properties, such as wrinkle reduction, often struggle to penetrate the skin's stratum corneum (skin barrier). Therefore, to exert anti-aging effects, these materials must pass through the skin barrier and reach fibroblasts in the dermal layer. In this study, deformable liposomes were developed for efficient transdermal delivery of retinol, a well-known anti-wrinkle agent. Five formulations (ML-1 to ML-5) were prepared using hydrogenated lecithin (HL) and mannosylerythritol lipid (MEL) as an edge activator with HL:MEL mass ratios of 10:0, 7:3, 5:5, 3:7, and 0:10. Their physicochemical properties, including particle size, zeta potential, polydispersity, encapsulation efficiency and deformability index were analyzed. For the optimal formulation, the liposome morphology was observed using cryo-TEM, and the retinol skin penetration ability of each liposome formulation was evaluated using a Franz diffusion cell. Their physicochemical properties were investigated, and ML-4 with an HL:MEL mass ratio of 3:7 was identified as the optimal formulation for transdermal delivery (particle size 89.3±6.8 nm, zeta potential -25.2±1.1 mV, polydispersity index 0.263±0.012, encapsulation efficiency 86.3±2.3%, and deformability index 5.76±1.9). Cryo-TEM analysis confirmed the liposomal morphology of ML-4. The retinol skin penetration ability of each formulation was evaluated using the Franz diffusion cell, with the conventional liposome (ML-1) without MEL as the control. The ML-4 formulation achieved a total retinol penetration of 29.0%, a 10.6% increase compared to ML-1 (18.4%). In this study, the ML-4 deformable liposome formulation, using MEL as an edge activator, efficiently encapsulates retinol, a wrinkle improvement agent, and improves skin penetration without causing physical damage. These findings suggest that ML-4 can serve as an efficient transdermal delivery system for functional cosmetic materials.
Stratum corneum lipid remodeling as a proposed mechanism for liposomal penetration enhancement [PMID: 42242510 · 2026]
The stratum corneum (SC) is the principal barrier to topical and transdermal delivery, yet how lipid-based formulations interact with the SC lipid matrix remains incompletely resolved. Here, we compared conventional lecithin/cholesterol liposomes, hexosomes, ultradeformable liposomes, and a surfactant-only micelle control in ex vivo human skin after 4 h Franz-cell exposure. Depth-resolved Laurdan generalized polarization (GP) imaging of cryosections was used to quantify formulation-induced changes in SC lipid organization, while DiD fluorescence and deuterated-lipid stimulated Raman scattering (SRS) provided orthogonal readouts of formulation-derived material within the tissue. Across formulations, GP decreased relative to matched controls, with the largest effects in the outer SC. Hexosomes produced larger outer-SC GP reductions than conventional liposomes (ΔGP ≈ 0.25-0.33 vs 0.14-0.18). In a separate donor-matched series, ultradeformable vesicles induced stronger SC remodeling than conventional liposomes, whereas Tween 20 micelles produced smaller effects. DiD and SRS signals were predominantly localized to the SC and decreased with depth, with SRS indicating a more surface-weighted distribution for rigid liposomes than for ultradeformable vesicles. Together, these findings identify formulation-dependent SC lipid remodeling, involving lipid redistribution and reduced local packing order, as a plausible mechanism by which lipid-based formulations may contribute to penetration enhancement reported in previous studies.
Impact of cationic, anionic, and amphiphilic emulsifiers on the physicochemical properties and applications of xanthan gum-shea butter bigels [PMID: 42190786 · 2026]
Bigels (BGs) have gained significant interest as versatile semisolid systems capable of immobilising both hydrophilic and lipophilic phases, making them suitable carriers for drug delivery. The current paper discusses the formulation of bigels (BGs) by combining xanthan gum (XG) based hydrogel (HG) with shea butter-hempseed oil-based oleogel (OG). The influence of emulsifier types, sodium dodecyl sulfate (SDS), soy lecithin (SL) and cetyltrimethylammonium bromide (CTAB), along with varying polymer concentration (1-5% w/w), on the physicochemical properties of the BGs was systematically investigated and characterized. The prepared bigels showed high oil binding capacity (>95%), indicating good structural integrity. Microscopic analysis revealed that the BGs exhibited an oleogel (OG)-in-hydrogel (HG) dispersed system, corresponding to an oil-in-water (O/W) structure. Rheological studies revealed dominant elastic behaviour (G' > G''), with CTAB-based formulations showing greater network strength. Fourier-transform infrared (FTIR) confirmed successful integration of hydrogel and oleogel phases without significant chemical interactions. Differential scanning calorimetry (DSC) analysis indicated improved thermal stability with increasing XG concentration, along with variations in crystallinity depending on emulsifier type. The in vitro drug release studies of Mupirocin (Mup) were best fitted by Korsmeyer-Peppas and Peppas-Sahlin models, suggesting Fickian diffusion as the principal release mechanism, with SL-based bigels showing comparatively higher drug release (~46%), Furthermore, the Mup-loaded BGs exhibited significant antimicrobial activity against Staphylococcus aureus, with inhibition zones of approximately 2.9 cm, confirming their suitability for topical drug delivery applications.
A Kangfuxin-Loaded Lipid Gel for the Management of Radiation Dermatitis: Repair and Protection [PMID: 42173826 · 2026]
Radiation therapy often causes oxidative stress and inflammation in normal tissues due to the generation of excessive radiation-induced reactive oxygen species (ROS). This can subsequently lead to radiation-induced skin injury (RISI), which manifests as tissue damage ranging from dermatitis to ulcers. One approach to addressing these challenges is to develop biocompatible functional materials that can facilitate repair and improve treatment tolerance by neutralizing ROS. In this study, a water-responsive lipid gel (LG) delivery system was constructed using Kangfuxin liquid (KFX, the ethanol extract of Periplaneta americana L.), soybean lecithin (SPC), and glycerol dioleate (GDO), based on KFX's broad-spectrum free radical scavenging ability, anti-inflammatory properties, and prorepair properties. Due to the molecular self-assembly properties of SPC and GDO, the KFX LG system can physically cross-link to form an in situ gel barrier upon contact with water. The barrier exhibits exceptional tissue adhesion, long-term slow-release properties, and good biocompatibility. The versatile KFX LG system has also been found to effectively remove various types of free radicals and reduce levels of proinflammatory factors. In a mouse model of radiation dermatitis, the radioprotective properties of the KFX lipid gel were demonstrated to be effective in alleviating radiation dermatitis. This study explored the radioprotective potential of KFX LG biomaterials in the context of radiation dermatitis, highlighting the application of radioprotectants as a promising RISI treatment strategy.
Comparison of Selected Pro-Health Biologically Active Chemical Compounds in Salviae herba from Selected Species [PMID: 42123793 · 2026]
Pharmaceutical, cosmetic, and food industries have contributed to the increasing interest in herbal phytochemicals. Salvia , a multifunctional culinary herb, meets phytotherapeutic requirements in the treatment of heartburn, excessive sweating, flatulence, and mouth, throat, and skin inflammatory conditions. Salviae folium is used in conductive education, i.e., a unique rehabilitation method for individuals with neurological and motor disorders designed to help in learning to perform activities independently. The comparative analysis of bioactive chemical compounds in S. officinalis , S. officinalis subsp. lavandulifolia , and S. sclarea herb showed that S. officinalis had the highest concentration of exogenous amino acids (53 mg·g -1 DW), with a predominance of lecithin and phenylalanine, and endogenous amino acids were dominated by aspartic and glutamic acids. S. officinalis subsp. lavandulifolia was the richest source of omega-3, omega-6, and omega-9 fatty acids, followed by S. officinalis and S. sclarea . The vitamin C content was 4.9 ( S. sclarea )-14.4 mg·100 g -1 DW ( S. officinalis ). Phenolic acids were dominated by rosmarinic acid ( S. officinalis > S. officinalis sub. lavandulifolia > S. sclarea ) and ferulic acid ( S. officinalis > S. sclarea > S. officinalis sub. lavandulifolia ). Salvia sclarea is a rich source of p -coumaric acid. Among non-phenolic organic acids, the highest content of quinic and malic acids was found in S. sclarea and S. officinalis , respectively. The level of o -dihydroxyphenols was 2140 ( S. officinalis )-2222 mg CAE·100·g -1 DW ( S. sclarea) . The flavonoid content was 610 ( S. officinalis subsp. lavandulifolia )-347 mg RU·100 g -1 DW ( S. sclarea ). Flavonoids, flavonols, and flavanones were dominated by apigenin, kaempferol, and hesperidin, respectively. These metabolites may be potential components in phytotherapeutic products.
Assessment of skin permeation and anti-inflammatory efficacy of lornoxicam proniosomal topical gel formulations: a comparative study [PMID: 42084848 · 2026]
Lornoxicam (LX) is a potent non-steroidal anti-inflammatory drug (NSAID) whose long-term oral administration is limited by gastrointestinal adverse effects. The present study aimed to develop and evaluate LX-loaded proniosomal topical gels as a strategy to enhance dermal permeation and anti-inflammatory efficacy, with direct comparison to a conventional LX gel. LX-loaded proniosomal Gels were formulated by combining lecithin, cholesterol, and a non-ionic surfactant. A conventional gel formulation was also prepared to compare its effectiveness with the proniosomal gel formulation. The vesicle size, Polydispersity index (PDI), zeta potential (ZP), encapsulation efficiency, morphology, in vitro LX release, ex vivo , and finally, the anti-inflammatory efficacy of both formulations was thoroughly characterized. For the proniosomal variants, vesicle sizes were recorded at 373 ± 29 nm for Span 60-based proniosomes (NS) and 230 ± 28 nm for Tween 80-based proniosomes (NT), with corresponding PDI values of 0.23 and 0.31 and zeta potentials of -26 mV and -28 mV, respectively. Encapsulation efficiency exceeded 88% across both formulations. Notably, ex vivo evaluations demonstrated markedly improved skin permeation in the proniosomal gels. The Fluxes measured 51. µg/cm 2 /h. for NS, 18.7 relative to the standard gel (12.4). These findings were corroborated by anti-inflammatory efficacy studies, which revealed statistically significant improvements with the proniosomal gel ( p  < 0.05) compared to the standard formulation.
Photodynamic Versus Sonodynamic Therapy In Vitro: Antimicrobial Activity of Liposomal Rose Bengal [PMID: 42083964 · 2026]
To compare the antimicrobial effect of Photodynamic (PT) and Sonodynamic Therapy (ST) applying Rose Bengal (RB) loaded in liposomes, intended for the treatment of skin infections. Formulations with standard soy lecithin (TSRB) and water-soluble soy lecithin (TWRB) were prepared and characterized by: (i) FTIR-ATR and DSC, and measuring size, polydispersity index, and zeta potential; (ii) in vitro release and permeation tests, visualizing the distribution of RB in the skin by confocal laser microscopy; (iii) stability tests under different conditions; (iv) occlusion capacity tests; (v) determination of antimicrobial activity against methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa; and (vi) cytotoxicity tests with HaCaT keratinocytes. Both formulations exhibited encapsulation rates > 93% and particle sizes < 100 nm. TWRB was more stable, delaying RB release (12.8 % at 8h) and facilitating its penetration into the skin. MRSA was inhibited with PT and ST. P. aeruginosa was inhibited with TWRB/ST. Viability was >80% in HaCaT keratinocytes treated with TWRB/PT; however, acoustic cavitation caused significant cell detachment, precluding cytotoxicity assessment in ST assays. TWRB exhibited good technological and stability properties, capable of delaying RB release while enhancing its penetration into the skin. Although MRSA (Gram-positive) was inhibited, the most interesting results were obtained with P. aeruginosa (a Gram-negative bacterium, difficult to eradicate), as TWRB/ST completely inhibited it at a lower concentration than the RB solution. The results, particularly with P. aeruginosa, provide a basis for further studies using this system.
Pregabalin-loaded transferosomal gel for enhanced topical delivery in peripheral neuropathy: formulation, in vitro and ex vivo evaluation [PMID: 42083811 · 2026]
To formulate and evaluate a pregabalin-loaded transferosomal gel for transdermal delivery aimed at, improving skin penetration, sustaining drug release, and increasing patient compliance in the management of peripheral neuropathy. Oral pregabalin therapy often leads to systemic side effects and variable pharmacokinetics. A transferosome-based gel offers a novel approach to improve dermal penetration, prolong drug release, and reduce systemic exposure, potentially enhancing therapeutic outcomes in neuropathic pain. Pregabalin-loaded transferosomes were prepared using the thin-film hydration method with soya lecithin and Tween 80 in varying ratios. Formulations were evaluated for particle size, polydispersity index, zeta potential, entrapment efficiency, and morphology. The optimized formulation was incorporated into a gel and assessed for pH, drug content, in vitro drug release, ex vivo permeation through goat ear skin, irritancy using the hen's egg test on the chorioallantoic membrane, and stability for 90 days. The vesicles displayed particle sizes of 378.9-1471 nm, a PDI of 0.3-0.8, and a zeta potential from -17.2 to -31.6 mV. Entrapment efficiency[ee] ranged from 40.35% to 89.2%. Scanning electron microscopy confirmed smooth, spherical vesicles. The transferosomal gel showed pH 5.2-6.1 and drug content of 93.4%-98.8%. In-vitro studies demonstrated sustained 24-hour release following the Korsmeyer-Peppas model. Ex-vivo permeation showed 92.2% permeation, a flux of 467.18 µg/cm 2 /h, and a lag time of 0.99 h. The gel was nonirritant and stable for 90 days. The developed transferosomal gel exhibited sustained release, efficient permeation, and good stability, indicating strong potential as a transdermal system for peripheral neuropathy management.
Cationic Corona-Engineered Polymer-Lipid Hybrid Nanoparticles for Enhanced Dermal Penetration and Cellular Bioavailability [PMID: 41937363 · 2026]
Cationic polymer-lipid hybrid nanoparticles were engineered to overcome cytotoxicity limitations of conventional surfactants while achieving enhanced skin penetration and controlled drug release. Poly(2-ethyl-2-oxazoline)- block -poly(ε-caprolactone) (POx- b -PCL) copolymers were synthesized via ring-opening polymerization and coassembled with lecithin through nanoprecipitation, yielding spherical nanoparticles (∼120 nm). Differential scanning calorimetry and NMR relaxometry confirmed that POx- b -PCL incorporation progressively increased the crystallinity and rigidity of the nanoparticle core, achieving 2-fold reduction in Higuchi release rate constants for sustained curcumin delivery. Biolayer interferometry demonstrated 10-fold enhanced binding affinity toward negatively charged albumin through multivalent electrostatic interactions, correlating with substantially improved cellular internalization in HaCaT keratinocytes. Confocal microscopy of ex vivo porcine skin revealed 70% increased transdermal penetration depth, with maximum fluorescence at 30-40 μm beneath the stratum corneum. These biocompatible nanocarriers synergistically integrate controlled release kinetics with cationic surface chemistry, presenting a promising platform for transdermal drug delivery and topical therapeutic applications.
Frequently Asked Questions (AEO Position 0)
- Q1. What are the official 7-track regulatory label names for LECITHIN?
- Standard label names are US PCPC INCI: 'LECITHIN', EU CosIng: 'LECITHIN', KR MFDS: 'LECITHIN (KR MFDS Registered)', CN NMPA IECIC: '卵磷脂', and JP JCIA: 'LECITHIN'.
- Q2. Is LECITHIN 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 LECITHIN?
- In emulsion_cream systems, LECITHIN is typically formulated between 0.05% and 5% (median 0.75%), with an optimal stability window of pH 4–8.
- Q4. What are the known formulation incompatibilities and synergy pairings for LECITHIN?
- Recommended synergy pairings include GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL. Key incompatibilities to avoid: Verify phase compatibility under extreme pH or high electrolyte loads.