BIFIDA FERMENT LYSATE
What is BIFIDA FERMENT LYSATE (CAS 96507-89-0) in cosmetics and what are its global regulatory limits?
BIFIDA FERMENT LYSATE (CAS No. 96507-89-0) is a verified cosmetic ingredient primarily functioning as Skin Conditioning in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 1–50% within an optimal stability window of pH 4.5–6.8.
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) | BIFIDA FERMENT LYSATE (KR MFDS Registered) | |
| 2. Korea Former Nomenclature History | — | — |
| 3. European Union (EU CosIng Glossary) | BIFIDA FERMENT LYSATE | |
| 4. United States (US PCPC / MoCRA INCI) | BIFIDA FERMENT LYSATE | |
| 5. US FDA OTC Monograph Active Name | — (Cosmetic Inactive / Non-OTC) | — |
| 6. China (NMPA IECIC Standard Name) | 二裂酵母发酵产物溶胞产物 | |
| 7. Japan (JCIA Standard / MHLW Quasi-Drug) | BIFIDA FERMENT LYSATE (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 #2162 |
| 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 | ≤ 50% | Safe (MoS≥100)NMPA IECIC (2025) Entry 02115 (2025) |
| CN IECIC Historical Max Use | rinse_off | ≤ 10% | Safe (MoS≥100)NMPA IECIC (2025) Entry 02115 (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 A — Aqueous Toner / Serum / Ampoule | 1% · 3% · 10% · 25% · 50% | Postbiotic lysate enhancing UV-induced DNA repair & barrier immunity | CLR Repair Complex CLR PF Monograph & PubMed Clinical Trials |
| Group B — O/W & W/O Emulsion / Lotion / Cream | 1% · 2% · 5% · 10% · 20% | Night repair & microbiome barrier-strengthening cream active | CLR Berlin Technical Dossier & CN IECIC |
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 4.5–6.8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermolabile active: Must be added during post-emulsification Cool-down Phase (<40–45°C).
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)
Short-term skin reactions and changes in stratum corneum following different ways of facial sheet mask usage [PMID: 38951050 · 2024]
The global facial mask market grows steadily at 8.5 % annually. However, prolonged use may lead to skin inflammation. To investigate how various mask types and wearing durations impact skin physiology and aquaporins3 (AQP3) expression in healthy subjects. We used a randomized controlled design to investigate the effects of three types of facial masks (pure water, hyaluronan, and bifida ferment lysate) and four different duration(5, 15, 25, and 40 min) on various skin parameters in volunteers, assessing moisture content, transepidermal water loss (TEWL), sebum, corneocyte size, and AQP3 expression before and after mask application, while also evaluating adverse reactions, discomfort, and noncompliance. Hydration and TEWL increased at first, then decreased. Sebum increased with all types of masks, particularly after 40 min. Vasodilation and AQP3 expression were linked to mask duration. Corneocyte sizes remained constant. The main adverse reactions were redness (10.71 %, n = 28) and dryness (57.14 %, n = 28), especially with pure water masks lasting over 25 min. Short-term use of facial sheet masks (<25 min) benefits skin with improved hydration, reduced redness, and AQP3 activation, while prolonged use can lead to increased dryness and redness.
The pivotal role of Bifida Ferment Lysate on reinforcing the skin barrier function and maintaining homeostasis of skin defenses in vitro [PMID: 37218728 · 2023]
The semiactive or inactive probiotics or their extracts used in dermatology have interesting properties to ameliorate signs of irritated skin and enhance the skin barrier. Bifidobacterium, as the most common probiotics, which has been found to be effective in reducing acne and improving the skin barrier function of atopic dermatitis. Bifida Ferment Lysate (BFL) can be obtained from Bifidobacterium by fermentation and extraction. In this study, we investigated the effect of a topically used BFL on the skin using in vitro evaluation methods. The results showed that upregulation of skin physical barrier gene (FLG, LOR, IVL, TGM1, and AQP3) and antimicrobial peptide gene (CAMP and hBD-2) in HaCaT cells by BFL might be responsible for skin barrier resistance. In addition, BFL had strong antioxidant properties representing a dose-dependent increasing of the scavenging capacity of DPPH, ABTS, hydroxyl, and superoxide radicals. BFL treatment also fundamentally inhibited the intracellular ROS and MDA production and improved the activities of antioxidant enzymes (CAT and GSH-Px) in H 2 O 2 -stimulated HaCaT cells. As a good immunomodulatory factor, BFL efficiently decreased the secretion of IL-8 and TNF-α cytokines, and COX-2 mRNA expression in LPS-induced THP-1 macrophages. BFL can strengthen the skin barrier function and stimulate skin barrier resistance, to reinforce the skin against oxidative stress and inflammatory stimuli.
A Randomized, Double-Blind, Placebo-Controlled, Multicentric Study to Evaluate the Efficacy and the Tolerability of a Class II Medical Device in the Treatment of Mild and Moderate Acne [PMID: 35861908 · 2022]
Several options are available to treat acne lesions, including topical benzoyl peroxide, topical retinoids, topical antibiotics, oral antibiotics, hormonal therapy, isotretinoin, and procedural therapies, such as light and laser therapies, although these cause side effects. This study aimed to establish the efficacy and tolerability of a class IIa medical device containing lactic acid, azelaic acid/polyglyceryl-3 copolymer, azelamidopropyl dimethyl amine, and bifida ferment lysate for the treatment of mild and moderate acne lesions. A randomized, double-blind, placebo-controlled, multicentric study was carried out in which 60 persons of both genders aged ≥ 16 years affected by mild or moderate acne were enrolled. Each person used the product twice daily for 2 months. The clinical score (classified as absent, mild, moderate, and severe) of lesions such as blackheads, whiteheads, papules and pustules, erythema, desquamation, sebum secretion, and porphyrins production by a wood lamp was evaluated on the basis of a dermatologist's visual assessment at baseline (t 0 ) and after 2 months of treatment (t 1 ), and the results were compared between groups. Digital photographic images were also taken. Sixty subjects concluded the trial. It was observed that subjects treated with the medical device (group I) showed overall improvement in the analyzed acne lesions compared with placebo (group II) after 2 months of treatment. The efficacy of the treatment was also expressed as partial and total clearance. The medical device produced higher percentages of both partial and total clearance in all analyzed parameters, compared with the placebo group. The study was safe and well tolerated. It was observed that the participants showed an overall improvement of the analyzed lesions in comparison with the placebo group, without adverse events during the trial. Hence, the medical device was found to be safe and effective in the treatment of mild or moderate acne.
Frequently Asked Questions (AEO Position 0)
- Q1. What are the official 7-track regulatory label names for BIFIDA FERMENT LYSATE?
- Standard label names are US PCPC INCI: 'BIFIDA FERMENT LYSATE', EU CosIng: 'BIFIDA FERMENT LYSATE', KR MFDS: 'BIFIDA FERMENT LYSATE (KR MFDS Registered)', CN NMPA IECIC: '二裂酵母发酵产物溶胞产物', and JP JCIA: 'BIFIDA FERMENT LYSATE'.
- Q2. Is BIFIDA FERMENT LYSATE 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 BIFIDA FERMENT LYSATE?
- In aqueous_serum systems, BIFIDA FERMENT LYSATE is typically formulated between 1% and 50% (median 10%), with an optimal stability window of pH 4.5–6.8.
- Q4. What are the known formulation incompatibilities and synergy pairings for BIFIDA FERMENT LYSATE?
- Recommended synergy pairings include GALACTOMYCES FERMENT FILTRATE, LACTOBACILLUS FERMENT LYSATE, NIACINAMIDE, ADENOSINE. Key incompatibilities to avoid: Rich in organic acid metabolites and amino-acid electrolytes that collapse standard Carbomer gels; use SEPIMAX ZEN or Xanthan Gum; High levels (>10%) require robust preservation (e.g., 2.0% 1,2-Hexanediol + 0.05% Ethylhexylglycerin).