Ingredient Dictionary/bifida-ferment-lysate/BIFIDA FERMENT LYSATE
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Microbiome / Ferment

BIFIDA FERMENT LYSATE

Skin Conditioning
[EU CosIng Official Definition] Bifida Ferment Lysate is a lysate of the product obtained by the fermentation of Bifida
Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR

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
7-Track Official Statutory Label Names for BIFIDA FERMENT LYSATE
Jurisdiction TrackOfficial Statutory Label NameOne-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

Layer 1 Statutory Regulatory Limits Across 6 Regions for BIFIDA FERMENT LYSATE
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 #2162
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 BIFIDA FERMENT LYSATE
Assessment BasisApplication ScopeConcentration RangeVerdict & Dossier Reference
CN IECIC Historical Max Useleave_on≤ 50%Safe (MoS≥100)NMPA IECIC (2025) Entry 02115 (2025)
CN IECIC Historical Max Userinse_off≤ 10%Safe (MoS≥100)NMPA IECIC (2025) Entry 02115 (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

Aqueous Serum / Ampoulen=48
Min 1% · Q1 3% · Median 10% · Q3 25% · Max 50%
Emulsion / Creamn=42
Min 1% · Q1 2% · Median 5% · Q3 10% · Max 20%
Aqueous Serum / Ampoule — Postbiotic lysate enhancing UV-induced DNA repair & barrier immunity
Verified Source: CLR Repair Complex CLR PF Monograph & PubMed Clinical Trials (pubmed) · CLR Berlin 32 · K-Beauty 16
Typical Median: 10%

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

Layer 3 Formulation Concentration Quartiles by Product Category for BIFIDA FERMENT LYSATE
Formulation GroupMin – Q1 – Median – Q3 – Max (%)Role & MechanismSource ID
Group A — Aqueous Toner / Serum / Ampoule1% · 3% · 10% · 25% · 50%Postbiotic lysate enhancing UV-induced DNA repair & barrier immunityCLR Repair Complex CLR PF Monograph & PubMed Clinical Trials
Group B — O/W & W/O Emulsion / Lotion / Cream1% · 2% · 5% · 10% · 20%Night repair & microbiome barrier-strengthening cream activeCLR Berlin Technical Dossier & CN IECIC
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

Freely miscible with water
Optimal Formulation pH Stability Window (0–14)pH 4.5 – 6.8
0245.5791114

Outside pH 4.5–6.8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.

Maximum Thermal Processing Limit (°C)≤ 45°C
25°C45°C60°C75°C85°C100°C

Thermolabile active: Must be added during post-emulsification Cool-down Phase (<40–45°C).

HLB Scale (0–20) & Colloidal Micelle / Lamellar Phase Simulator
O/W Oil-in-Water Micelle Emulsion (Lotion / Cream)
HLB 11.5
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)

+ GALACTOMYCES FERME…+ LACTOBACILLUS FERM…+ NIACINAMIDE+ ADENOSINE✕ Rich in organic acid…✕ High levels (>10%) r…BIFIDA FERMENT LYS…
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))
Repair Complex CLR™ PFBifida Ferment Lysate 100

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: BIFIDA FERMENT LYSATE | CAS No.: 96507-89-0 | EC No.: 306-168-4 - Origin: FERMENT | Functions: Skin Conditioning - Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: amphoteric | CosIng/MFDS - Official Regional Label Names: US [BIFIDA FERMENT LYSATE] · EU [BIFIDA FERMENT LYSATE] · CN [二裂酵母发酵产物溶胞产物] · JP [-] · JP Quasi-Drug [-] ■ [2. Dermatological Mechanism of Action & Functional Role] - Bifida Ferment Lysate is a lysate of the product obtained by the fermentation of Bifida Classified under origin 'ferment', 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. 2162 (二裂酵母发酵产物溶胞产物)) - 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 50.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 10.0% ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [aqueous_serum] Typical range: 1.0 ~ 50.0% (Median 10.0%, Ref: CLR Repair Complex CLR PF Monograph & PubMed Clinical Trials) — Postbiotic lysate enhancing UV-induced DNA repair & barrier immunity - [emulsion_cream] Typical range: 1.0 ~ 20.0% (Median 5.0%, Ref: CLR Berlin Technical Dossier & CN IECIC) — Night repair & microbiome barrier-strengthening cream active ■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)] - Addition Phase: Cool-down Phase (< 40°C) - Optimal pH Range: pH 4.5 ~ 6.8 | Max Process Temp: Max 45°C | Electrolyte Tolerance: NONE - Incompatibility / Caution: Rich in organic acid metabolites and amino-acid electrolytes that collapse standard Carbomer gels; use SEPIMAX ZEN or Xanthan Gum - Incompatibility / Caution: High levels (>10%) require robust preservation (e.g., 2.0% 1,2-Hexanediol + 0.05% Ethylhexylglycerin) - Synergy Pairings: GALACTOMYCES FERMENT FILTRATE, LACTOBACILLUS FERMENT LYSATE, NIACINAMIDE, ADENOSINE | Reference Trade Names: Repair Complex CLR™ PF, Bifida Ferment Lysate 100 ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 38951050 (2024, J Tissue Viability): Short-term skin reactions and changes in stratum corneum following different ways of facial sheet mask usage - PMID 37218728 (2023, J Cosmet Dermatol): The pivotal role of Bifida Ferment Lysate on reinforcing the skin barrier function and maintaining homeostasis of skin d - PMID 35861908 (2022, Dermatol Ther (Heidelb)): A Randomized, Double-Blind, Placebo-Controlled, Multicentric Study to Evaluate the Efficacy and the Tolerability of a Cl

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]
Wang Y, Cao Y, Huang X, Zhang M, Hu J, Li L, Xiong L · J Tissue Viability (2024)

The global facial mask market grows steadily at 8.5&#xa0;% 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&#xa0;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&#xa0;min. Vasodilation and AQP3 expression were linked to mask duration. Corneocyte sizes remained constant. The main adverse reactions were redness (10.71&#xa0;%, n&#xa0;=&#xa0;28) and dryness (57.14&#xa0;%, n&#xa0;=&#xa0;28), especially with pure water masks lasting over 25&#xa0;min. Short-term use of facial sheet masks (&lt;25&#xa0;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]
Wang R, Yan S, Ma X, Zhao J, Han Y, Pan Y, Zhao H · J Cosmet Dermatol (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-&#x3b1; 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]
Fabbrocini G, Ferrillo M, Donnarumma M, Papale A, Pinto D, Rinaldi F · Dermatol Ther (Heidelb) (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&#x2009;&#x2265;&#x2009;16&#xa0;years affected by mild or moderate acne were enrolled. Each person used the product twice daily for 2&#xa0;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&#xa0;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&#xa0;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).