Supplements · General functional
Nattokinase
ナットウキナーゼ (Nattō kināze)
Also known as: Natto enzyme, Bacillus subtilis natto protease
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| Category | Supplements |
|---|---|
| Common Japanese notations | ナットウキナーゼ, 納豆キナーゼ |
| CAS number | 133876-92-3↗ |
| Origin | Fermented (Bacillus subtilis var. natto) |
| Typical functions | Smooth blood flow (FFC endpoint) |
| Regulatory status in Japan | FFC-accepted for smooth blood flow endpoints. Industry body JNKA sets purity and activity standards. |
Nattokinase is a fibrinolytic serine protease (EC 3.4.21.62) identified in 1980 by Dr. Hiroyuki Sumi from the sticky coating of natto. Japanese manufacturers — led by JBSL since 1998 — have developed high-activity concentrates (measured in Fibrinolytic Units, FU) that are now widely used in cardiovascular-positioned supplements globally.
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Classification
Tags below link to other ingredients sharing the same attribute, so you can pivot from one ingredient to its peers.
Product applications
Functions
Regulatory tags
Common OEM product categories
Finished-product categories where Japanese OEM manufacturers commonly formulate with this ingredient.
- Cardiovascular-positioned supplements
- Functional capsules
Ingredient profile
A 275-amino-acid serine protease produced exclusively by Bacillus subtilis var. natto during soybean fermentation. Molecular weight approximately 27,700 Da. Activity is measured in FU (Fibrinolytic Units) using the fibrin-plate method.
Imitation products sold in several overseas markets use different enzymes (subtilisin NAT, Korean chungkookjang kinase, fungal proteases). Buyers should verify B. subtilis natto origin and the presence of the JNKA mark. Vitamin K2-reduced grades are available for formulations requiring compatibility with anticoagulant medications.
OEM applications
Cardiovascular-positioned supplements (capsules, tablets) — the primary application.
Functional foods with FFC notifications on smooth blood flow.
Regulatory classification in Japan
Accepted as a Foods with Function Claims (FFC) ingredient for smooth blood flow endpoints; JNKA mark requires 2,000+ FU per daily dose.
Confirm vitamin K2 removal if targeting users on warfarin-type medications; clinical precaution required regardless of supplement status.
Regulatory classification in other markets
| USA | Dietary supplement under DSHEA. Safety/labeling disclosures apply. |
|---|---|
| EU | Food supplement category; novel food evaluation may apply for specific extract preparations. Verify with current EFSA guidance. |
| China / Korea / Taiwan | Registered supplement ingredient; verify local labeling norms. |
Market reference formulations
Example finished products and brands will be added after ingredient-list verification. Avoid citing medical-disease claims; restrict descriptions to FFC-accepted wording.
All brand names and product names referenced anywhere on this site are the property of their respective owners. Example entries are provided for informational purposes only and do not imply endorsement.
Typical OEM use levels
Formulation ranges per finished-product application. Verify against the cited source before production.
| Application | Typical range | Regulatory limit | Notes |
|---|---|---|---|
| Functional Food (FFC) — blood circulation / fluidity claim (Japan) | Daily intake 2,000 FU (fibrinolytic units) per FFC notifications (representative) | Per consumer-affairs notification; published in 機能性表示食品DB | 消費者庁 機能性表示食品データベース |
Storage requirements
How the receiving OEM facility needs to handle inbound raw material.
- Temperature
- Refrigerated 4°C for activity retention; freezer for stock
- Conditions
- Sealed against moisture; activity (FU) declines under heat / humidity
- Shelf life
- 24 months sealed cold; activity loss accelerates above 25°C
Industry stability data + 日本ナットウキナーゼ協会
Supply concentration
Where this ingredient comes from — useful for single-source-risk planning.
- Primary regions
- Ibaraki, Tochigi (natto industry centers); Daiwa Pharmaceutical and JBSL major producers
- Import dependence
- Premium grade is domestic; commodity supply also from Korea / China
日本ナットウキナーゼ協会
Certifications commonly available
Certification schemes commonly obtainable for this raw material. Always confirm the specific supplier's current certificate before contracting.
| Scheme | Availability | |
|---|---|---|
| GMP (food / supplement) | Standard | Required for FFC notification |
| Halal | On-request | Bacillus-fermentation source can be Halal-cert; specific suppliers (e.g., JBSL) carry cert |
| Kosher | On-request | |
| Vegan | Common | Bacillus-derived; non-animal |
| Non-GMO | On-request | Soy substrate sourcing matters |
| FFC notification ready | Standard | Most suppliers provide 機能性表示食品 dossier-ready material |
Alternative ingredients
Related ingredients commonly evaluated as substitutes.
Quick answers
- What is Nattokinase?
- Nattokinase is a fibrinolytic serine protease (EC 3.4.21.62) identified in 1980 by Dr. Hiroyuki Sumi from the sticky coating of natto. Japanese manufacturers — led by JBSL since 1998 — have developed high-activity concentrates (measured in Fibrinolytic Units, FU) that are now widely used in cardiovascular-positioned supplements globally.
- What is the regulatory status of Nattokinase in Japan?
- FFC-accepted for smooth blood flow endpoints. Industry body JNKA sets purity and activity standards.
- What products typically use Nattokinase?
- Cardiovascular-positioned supplements / Functional capsules
- Where does Nattokinase come from?
- Fermented (Bacillus subtilis var. natto)
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Related guides & how-to
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Regulatory guidance
Take the next step
FAQ for OEM buyers
Q. What is nattokinase?
Nattokinase is a fibrinolytic serine protease (EC 3.4.21.62) of approximately 27.7 kDa, identified by Dr. Hiroyuki Sumi in 1980 from the sticky coating of natto (Japanese fermented soybeans).
Q. How is nattokinase activity measured?
Activity is conventionally measured in Fibrinolytic Units (FU) using the fibrin-plate method. The Japan NattoKinase Association (JNKA) sets purity and activity standards used in the Japanese market.
Q. Is all nattokinase the same?
No — only enzymes produced by Bacillus subtilis var. natto qualify as authentic nattokinase. Some imitation products use other enzymes such as subtilisin or fungal proteases. Buyers should verify the production strain and look for the JNKA mark.
Q. What is the FFC endpoint commonly notified for nattokinase in Japan?
Common FFC notifications cite a smooth blood flow endpoint. Specific brand-claim wording must follow each individual notification on file with the Consumer Affairs Agency.
Use cases
Cardiovascular-positioned supplements (capsules)
- Positioning
- Smooth blood flow under FFC where notified
- Typical usage level
- ≥2,000 FU per daily dose for JNKA-certified products
- Formulation notes
- Enteric coating common; protect from heat and humidity
FFC functional foods
- Positioning
- Smooth blood flow positioning
- Formulation notes
- Endpoint wording must mirror individual FFC notification
Export supplements (US/EU/Asia)
- Positioning
- Cardiovascular wellness — non-disease, non-drug claims only
- Formulation notes
- Verify EU novel-food status of the specific extract; localize labeling
Sources
Search the academic literature
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Official regulatory databases
External links to public Japanese / international regulatory authorities. We are not affiliated.
References
- Japan Nattokinase Association (JNKA) standards
- FFC database — Consumer Affairs Agency
Last updated: 2026-04-23. Ingredient entries are reviewed at least annually against current regulatory listings.