LACTOBIONIC ACID
What is LACTOBIONIC ACID (CAS 96-82-2) in cosmetics and what are its global regulatory limits?
LACTOBIONIC ACID (CAS No. 96-82-2) is a verified cosmetic ingredient primarily functioning as pH Adjuster, Buffering in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 0.1–5.0% within an optimal stability window of pH 4.5–7.5.
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) | LACTOBIONIC ACID (KR MFDS Registered) | |
| 2. Korea Former Nomenclature History | — | — |
| 3. European Union (EU CosIng Glossary) | LACTOBIONIC ACID | |
| 4. United States (US PCPC / MoCRA INCI) | LACTOBIONIC ACID | |
| 5. US FDA OTC Monograph Active Name | — (Cosmetic Inactive / Non-OTC) | — |
| 6. China (NMPA IECIC Standard Name) | 乳糖酸 | |
| 7. Japan (JCIA Standard / MHLW Quasi-Drug) | LACTOBIONIC ACID (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 #5692 |
| 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 | ≤ 8% | Safe (MoS≥100)NMPA IECIC (2025) Entry 05692 (2025) |
| CN IECIC Historical Max Use | rinse_off | ≤ 5% | Safe (MoS≥100)NMPA IECIC (2025) Entry 05692 (2025) |
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 4.5–7.5, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 70°C during standard emulsification.
Cellular & Molecular Target Mechanism Flow
Academic & Toxicological Synthesis
Tier 2 SynthesisSynthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.
Linked Peer-Reviewed Literature (NIH PubMed) (12)
Insights Into the Characterization and Application of Pseudomonas taetrolens [PMID: 41914170 · 2026]
Pseudomonas taetrolens is a highly versatile microorganism that has gained significant attention in biotechnology due to its metabolic adaptability and ability to thrive in diverse environmental conditions. Thus, since P. taetrolens efficiently metabolizes organic compounds, P. taetrolens is a promising candidate for sustainable industrial applications. P. taetrolens demonstrates substantial potential in waste utilization by converting dairy byproducts, such as whey, into value-added compounds, including lactobionic acid, thereby advancing the principles of circular economic frameworks. This review provides a comprehensive analysis of the characterization, structural features, and diverse applications of P. taetrolens . In particular, this review explores the enzymatic mechanisms underlying the metabolic pathways of P. taetrolens , focusing on its role in lactose oxidation into lactobionic acid. Additionally, this review underscores the potential of microorganisms in industrial biotechnology and sustainable development practices by showcasing recent advances and ongoing research. This analysis demonstrates how P. taetrolens contributes to innovative solutions in waste utilization, environmental sustainability, and the production of value-added compounds across sectors, including food, pharmaceuticals, and cosmetics.
Chemical Versus Biological Approaches to the Synthesis of Lactobionic Acid: A Review [PMID: 40871484 · 2025]
Lactobionic acid, widely used in the pharmaceutical, cosmetic, and food industries, is produced through chemical and biological methods, each with distinct advantages and challenges. This review examines the key approaches to its production, highlighting the chemical oxidation of lactose and biotechnological processes using microbial and enzymatic systems. Chemical methods offer high yields and rapid production but are often hindered by environmental concerns and lower product purity. In contrast, biological methods provide eco-friendly alternatives with superior product quality, albeit with limitations in scalability and higher initial costs. The comparison in this overview focuses on productivity, cost efficiency, purity, and environmental impacts, underscoring the potential of biological methods to align with sustainability goals. This review highlights further advances in biological approaches and explores hybrid solutions that combine the strengths of both methods for optimal lactobionic acid production.
Emulgels powered by coco-glucoside: A stable and effective synbiotics delivery system for skin care [PMID: 40845989 · 2025]
The synergy of prebiotics and probiotics in the form of emulgels offers a promising solution and may be an essential strategy for delivering bioactive substances to protect the skin. In this study, a series of emulgels were created by incorporating Lactobacillus rhamnosus (L. rhamnosus), Lactobacillus plantarum (L. plantarum), and Lactobacillus acidophilus (L. acidophilus) with lactobionic acid, xylitol, and inulin. Additionally, the surfactant coco-glucoside (CG) was used to formulate the emulgel, which served as a crucial emulsifier. To gain a comprehensive understanding of the emulgels, several analyses were conducted. These included examinations of their microscopic structure, physicochemical properties (such as pH, density, and acidity), spreadability, stability under various conditions (including temperature and centrifugation), and rheological characteristics. Furthermore, sensory evaluations and surface texture analysis using atomic force microscopy (AFM) were conducted to determine their suitability for cosmetic products. Experimental data confirmed that all emulgels maintained stability, which was linked to the absence of phase separation. Key metrics showed spreadability ranged from 38.7 to 48.3 mm, pH from 3.55 to 5.64 and density from 0.87 to 0.99 g/mL. The unique formulation of the developed emulgels offers adequate support for the skin's natural barrier, creating a stable environment that preserves the viability of probiotics for up to 11 days. This represents an innovative approach to designing advanced active substance delivery systems for the skin. Our results provide a strong foundation for the creation and enhancement of emulgels made with nonionic surfactant, presenting promising and reliable methods for developing sophisticated skincare products.
Influence of Lactobionic Acid on Hydration and Elasticity Parameters in Women Aged 30-40 and 50-60 Years in Comparison to Mandelic Acid [PMID: 40095547 · 2025]
Background/Objectives : Mandelic acid as a chemical peel has been used in cosmetology for years and is being gradually exchanged for lactobionic acid. However, in the cosmetology literature, there is no information on the effectiveness of the aforementioned peels in terms of hydration and elasticity for women's facial skin depending on their age. The effects of lactobionic and mandelic acid on the skin of women aged 30-40 and 50-60 years are assessed in terms of their moisturizing and elasticizing effects. Methods : The participants of this study were 180 women aged 30-40 and 50-60 years. The selection of the group was random. Contraindications to the examination were excluded in all participants. The level of hydration was assessed using Tewameter and the level of elasticity using a cutometric probe (Courage-Khazaka Multi Test Skin Center MC 1000, Kőln, Germany). The participants also used a moisturizer. Moreover, a series of five exfoliating treatments using 40% mandelic acid or 40% lactobionic acid were performed in 120 of the participants. After 14 days since the last treatment, the assessment of their facial skin's hydration and elasticity was performed yet again. Results : In the case of women aged 30-40 years, the level of hydration and elasticity increased after using lactobionic and mandelic acid, as well as a moisturizer. In the group of older women aged 50-60 years, the level of elasticity increased after using both acids and moisturizer, but the hydration parameter increased only after the usage of lactobionic acid and moisturizer. Conclusions : In terms of age, lactobionic acid will be more suitable for people aged 50-60, while for women aged 30-40, lactobionic or mandelic acid can be used.
The assessment of the impact of carboxytherapy and selected chemical peels on cosmetic defects and signs of aging of skin around eyes [PMID: 39135491 · 2024]
The purpose of this study was to assess changes in skin elasticity and other skin defects related to the aging of skin around eyes following the use of combination treatment carboxytherapy and chemical peels (ferulic acid combined with ascorbic acid, lactobionic acid). A total of 39 Caucasian patients were subjected to a series of five combination carboxytherapy and chemical peels treatments at weekly intervals. The Cutometer device was used to objectively measure skin elasticity. The assessment was supplemented by photographic documentation. A statistically significant improvement in skin elasticity assessed on the basis of R2 and R7 parameters ( p  < .0001, p  = .001, respectively) was demonstrated after a series of five sessions of carboxytherapy combined with chemical peels. The improvement in the R2 parameter was observed in 82.1%, while R7 in 76.9% of study participants. It observed that the number of participants who benefited from treatment with ferulic acid and ascorbic acid was statistically higher compared with the second group ( p  = .036). Improved R2 values were reported in 100% of participants undergoing carboxytherapy combined with ferulic and ascorbic acid. Carboxytherapy in combination with chemical peels improved skin elasticity and can be used to reduce other skin defects.
Supportive treatment to chemotherapy with MMC, in patients with ocular surface squamous neoplasia or conjunctival melanocytic tumor [PMID: 36074189 · 2023]
Since there is a lack of clear information regarding the benefit to combine supportive therapies (such as artificial tears) to mitomycin C (MMC) in the treatment of ocular surface neoplasia, the primary purpose of the study was to evaluate hyaluronic acid eye drops and hyaluronic acid-conjugated lactobionic acid (LACTOyal FREE) eye drops as supportive therapy. Retrospective evaluation of patients with ocular surface squamous neoplasia or conjunctival melanocytic tumor treated with MMC, who had used also artificial tears as supportive treatment. A 6-month follow-up with evaluation of subjective and objective tests for ocular surface integrity was conducted. A total of 35 patients were analyzed, most of them with squamous disease (71.4%). The break-up time (BUT), Ocular Surface Disease Index (OSDI) and Schirmer test values showed a significant difference at any time point with overall population. No statistical difference was found among subgroups (Lactoyal vs No Lactoyal). The use of an ancillary therapy based on hyaluronic acid allows to improve both subjective and objective ocular parameters, reducing MMC induced adverse effects. Meantime, hyaluronic acid-conjugated lactobionic acid eye drops highlighted the same advantages with a more positive trend in OSDI results.
Efficacy and safety of a new peeling formulated with a pool of PHAs for the treatment of all skin types, even sensitive [PMID: 35796684 · 2023]
Actually, the use of chemical peels in cosmetics and dermatology continues to grow due to their versatility, clinical endpoint-directed predictability, and favorable risk profile in comparison to lasers. The chemical peel is a generally safe method for treatment of some skin disorders and to refresh and rejuvenate the skin. The major challenge of chemical peels is the tolerability, that is because of sensitive skin which is one of the most common skin disorders. The aim of this study was to evaluate the effectiveness of the new Miamo Renewal Peel Serum formulated with a pool of new generation acids (ELPA25™) on sensitive skin with respect to mandelic acid serum only and with respect to placebo comparison. The "in vivo" study following the half-face experimental protocol active versus placebo involved 30 healthy Caucasian female volunteers between 25 and 64 years, with sensitive skin, who were divided into two different groups. ELPA25™ serum was applied in one group three times a week for 8 weeks. The other group, with the same protocol, applied an active serum containing mandelic acid, as control, versus placebo. In particular, skin moisturizing, skin viscoelastic properties, skin surface smoothness, wrinkle reduction, and stratum corneum renewal were evaluated. Renewal Peel Serum was very well tolerated from sensitive skin. A significant decrease in skin roughness and wrinkle breadth, and an improvement in firmness and in skin elasticity, was observed after 2 months of treatment with respect both to mandelic acid serum and to placebo comparison. Scientific protocol using self-controlled study methodology and noninvasive skin bioengineering techniques with adequate statistical methods were able to evaluate both the safety and the efficacy of the new Miamo Renewal Peel Serum. This study highlighted that the Miamo Renewal Peel Serum formulated with a patent-pending mixture of new generation acids (ELPA25™) exerts many beneficial effects and it can be successfully employed for sensitive skin.
A Novel multi-fruit acids formula design on molecular basis for skin brightening via a system biology approach [PMID: 35713107 · 2022]
Fruit acids have long been recognized as highly effective actives with world-wide popularity, covering skin peeling, anti-acne, anti-wrinkle applications, and skin depigmentation. There are complicated interconnections between the fruit acid formula and skin pigmentation behaviors. However, the lack of systematic researches on multi-ingredient formula restricted our understanding on its mechanism. Therefore, it is of great necessity to study the interactions and cascades among components, potential gene targets, signaling pathways, and biological processes via a system biology approach. We used system biology, molecular fingerprint, and structural biology to calculate and collect target information of the functional formula. Gene Ontology (GO) enrichment analysis was further applied to study the biological processes and pathways of the formula, and a multi-level network model of "component - molecular target - signaling pathway - skin disease" was established. Besides, the zebrafish model was utilized to verify the formula. We obtained 69 hub targets by constructing a protein-protein interaction (PPI) network based on the intersection between multi-fruit acids formula (mandelic acid, lactobionic acid, niacinamide, and hydroxytyrosol) and skin indications targets (whitening-sebum balance). In vitro zebrafish models, including pigmentation, antioxidant, and radiation protection models, showed that the current formula significantly alleviated pigmentation intensity and intracellular free radical content, thus proving the efficacy of skin brightening and UV irradiation protection. This research uncovered the underlying mechanism of multi-fruit acids formula and predicted its function in skin brightening and UV irradiation prevention.
Efficient Production of Lactobionic Acid Using Escherichia coli Capable of Synthesizing Pyrroloquinoline Quinone [PMID: 35118861 · 2022]
Lactobionic acid (LBA) is an emerging chemical that has been widely utilized in food, cosmetic, and pharmaceutical industries. We sought to produce LBA using Escherichia coli . LBA can be produced from lactose in E. coli , which is innately unable to produce LBA, by coexpressing a heterologous quinoprotein glucose dehydrogenase (GDH) and a pyrroloquinoline quinone (PQQ) synthesis gene cluster. Using a recombinant E. coli strain, we successfully produced LBA without additional supplementation of PQQ, and changing the type of heterologous GDH improved the LBA production titer and productivity. To further enhance LBA production, culture conditions, such as growth temperature and isopropyl-β-d-1-thiogalactopyranoside concentration, were optimized. Using optimized culture conditions, batch fermentation of the recombinant E. coli strain was performed using a 5 L bioreactor. After fermentation, this strain produced an LBA titer of 209.3 g/L, a yield of 100%, and a productivity of 1.45 g/L/h. To our best knowledge, this is the first study to produce LBA using heterologous GDH in an E. coli strain without any additional cofactors. Our results provide a simple method to produce LBA from lactose in a naturally non-LBA-producing bacterium and lay the groundwork for highly efficient LBA production in E. coli , which is one of the most versatile metabolite-producing bacterial hosts.
Efficient isolation of new lactobionic acid-producing microorganisms from environmental samples by colloidal calcium carbonate agar plate-based screening [PMID: 35048174 · 2022]
Lactobionic acid (LBA) has recently emerged as an important substance in various industries, such as cosmetics, foods, and pharmaceuticals. In this study, we developed a simple, efficient, and high-throughput method for screening LBA-producing microorganisms. First, an agar plate was prepared to isolate LBA-producing microorganisms by utilizing the property of LBA to solubilize colloidal calcium carbonate (CaCO 3 ), resulting in the formation of a clear halo around colonies on a nutrient broth agar plate containing CaCO 3 . Subsequently, LBA production from the isolated microorganisms was confirmed using high-performance liquid chromatography (HPLC). Approximately 560 colonies from soil samples in Ulsan, Korea were screened and a clear halo was observed around three colonies on the prepared LBA-screening agar plate. The culture supernatants of these three colonies were analyzed by HPLC and it was found that these strains could produce LBA from lactose. Phylogenetic analysis by comparing their 16S rRNA nucleotide sequences revealed that these strains were Pseudomonas spp. and Alcaligenes faecalis. This is the first report highlighting that A. faecalis can produce LBA. As per the aforementioned results, the LBA-screening method that we devised here is highly effective for isolating and identifying new LBA-producing microorganisms.
The Impact of Carboxytherapy and Treatments Combining Carboxytherapy and Selected Chemical Peels on Vascular and Pigmentary Components of the Dark Circles [PMID: 39193094 · 2024]
Particular attention is given to the enhancement of melanin-related pigmentation (dark circles, photoaging) and vascular circles, which are commonly located in the tear trough. The objective of the study is to provide an objective evaluation of the impact of carboxytherapy and the treatment regimen combining carboxytherapy with lactobionic acid (20%, pH 2.1) or ferulic acid (14%, pH 4.0-5.0) and ascorbic acid (12%) on skin defects in the eye area. A group of 39 Caucasian people were subjected to a series of five carboxytherapy treatments (right eye area) and five treatments combining carboxytherapy with a selected chemical peel for the skin around the eyes (left eye area). The efficacy of therapy was assessed based on parameters (MI and EI) measured with the Mexameter probe. Measurements were made in the tear trough and the middle of the lower eyelid. We demonstrated that a series of carboxytherapy (right side) significantly statistically influenced the EI parameter (in different measurement points: P <0.0001, P = 0.015, P = 0.002), which reflects the intensity of vascular circles under the eyes. Improvement of this parameter by 7.2 units was also shown in the tear trough in 82.1% of participants after the application of carboxytherapy combined with acids (left side) on the valley of tears for this parameter (EI). Lactobionic acid and carboxytherapy were associated with a statistically significant improvement (P = 0.011) in the tear trough. In this study, a reduction in the combined pigmentation (MI plus EI) for both the right and left sides (p = 0.001 and p = 0.015, respectively) was observed. The study provides objective evidence for the effectiveness of sole carboxytherapy and carboxytherapy combined with acids in the reduction of dark circles, in particular vascular circles in the tear trough. Lactobionic acid, ferulic acid, and ascorbic acid can be used as safe supplements to enhance carboxytherapy.
Bioproduction and applications of aldobionic acids with a focus on maltobionic and cellobionic acid [PMID: 37058246 · 2023]
Aldobionic acids are sugar acids which consist of a disaccharide with an anomeric acid group. The most famous is lactobionic acid (LBA). LBA is used in many applications such as food and beverages, pharmaceuticals and medicine, cosmetics or chemical processes. During the last decade, all these industries are observing a shift of consumer preferences towards plant-based options. Thus, the biotechnological industry is trying to replace the animal-derived LBA. Maltobionic acid (MBA) and cellobionic acid (CBA) are two stereoisomers of LBA which have emerged as vegan alternatives. However, MBA and CBA face different obstacles related to their industrial production. While traditionally used electrochemical or chemical catalysis often rely on cost intensive and/or hazardous catalysts, novel production methods with microorganisms are still poorly studied. In the first part, this paper discusses both alternatives in terms of their characteristics and applications. In the second part, it reviews the long-studied chemical production and the novel bioproduction methods, which are based on enzymatic and microbial systems. This review concludes with a discussion of future work needed to bring their production to the industrial scale.
Frequently Asked Questions (AEO Position 0)
- Q1. What are the official 7-track regulatory label names for LACTOBIONIC ACID?
- Standard label names are US PCPC INCI: 'LACTOBIONIC ACID', EU CosIng: 'LACTOBIONIC ACID', KR MFDS: 'LACTOBIONIC ACID (KR MFDS Registered)', CN NMPA IECIC: '乳糖酸', and JP JCIA: 'LACTOBIONIC ACID'.
- Q2. Is LACTOBIONIC ACID 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 LACTOBIONIC ACID?
- Formulate within pH 4.5–7.5 and max process temperature ≤70°C.
- Q4. What are the known formulation incompatibilities and synergy pairings for LACTOBIONIC ACID?
- Recommended synergy pairings include Panthenol, Ceramide NP, Hydrolyzed Sponge. Key incompatibilities to avoid: Extreme pH or strong oxidizing agents.