Nattokinase Quality and Labeling Standard
JHFC-S-013 Enacted: 3 September 2026 / Effective: the same day
Japan Certified Health Food Council (JHFC) — English translation of the standard. In case of discrepancy the Japanese text prevails. Japanese original
Japan Certified Health Food Council (JHFC)
Enacted: 3 September 2026 / Effective: the same day
Preamble (Rationale for Enactment)
Nattokinase is traded as an enzyme fraction obtained from cultures or fermentation products of natto bacteria, but raw material powder amount, protein amount, and enzyme activity are not the same measure. Activity values depend on the substrate, reaction conditions, reference standard, and calculation method, and may change through heating, moisture exposure, or formulation processing. Fermented raw materials may also contain soybean components, culture medium components, and other enzymes. This Standard is established to enable traceability of strains and fermentation lots, enzyme identity, activity measurements, and labeling units.
Article 1 (Purpose)
The purpose of this Standard is to evaluate strain and culture origin, enzyme fraction identity, activity specifications and measurement conditions, content labeling, manufacturing and inactivation control, third-party testing, storage, and cautionary information for health foods containing nattokinase.
Article 2 (Scope)
This Standard applies to nattokinase-containing raw materials obtained through cultivation or fermentation of strains of the genus Bacillus managed as natto bacteria, and oral products formulated with these materials. Fermented soybean powder, natto powder, bacterial cell amount, or total protease activity shall not be declared as nattokinase activity without supporting evidence.
Article 3 (Terms and Definitions)
- 1. Nattokinase: An enzyme fraction obtained through fermentation of an identified natto bacterial strain and measured using a specified substrate under specified conditions.
- 2. Production strain: A microbial strain used in raw material production whose origin and preservation history are controlled.
- 3. Activity unit: A value defined by a test method specifying the substrate, reaction time, temperature, liquid properties, endpoint, and calculation method.
- 4. Enzyme fraction: A fraction containing nattokinase obtained from a culture by separation, concentration, purification, or drying.
- 5. Residual activity: Activity confirmed in a product after manufacturing or storage using the method employed for labeling.
Article 4 (Requirements)
- 1. Records for the production strain shall include strain identification information, the source from which it was acquired or isolated, preservation and passage history, and methods for controlling working seed cultures. Strain identity shall not rely solely on morphology or a general species name, and shall be checked against appropriate microbiological or genetic documentation. Assessment procedures shall be established for suspected strain changes or contamination.
- 2. The principal culture medium ingredients and the steps of seed cultivation, fermentation, solid-liquid separation, concentration, purification, drying, and carrier addition shall be recorded in lot records. Steps using soybeans shall be distinguished from those not using soybeans, and allergens originating from the culture medium and processing aids shall be evaluated. Process verification shall include the effects of heating, adjustment of liquid properties, and other operations on enzyme activity.
- 3. Enzyme fraction identity shall be confirmed by combining documentation appropriate to the production method concerning molecular size, peptide information, enzymatic properties, or separation patterns. Identification shall not be based solely on total protein amount, raw material powder amount, or a nonselective protease test, and the measurement response due to coexisting enzymes shall be evaluated. The business operator shall present identification specifications and their basis.
- 4. The activity test method shall clearly specify the substrate type and lot, reaction conditions, reaction termination or endpoint determination, reference standards, blank tests, and calculation method. When the method is changed or transferred to an external method, its relationship to the previous method shall be verified. Interference from coloring components, proteins, acidic components, and other substances in the final product, and extraction recovery from the product, shall be confirmed for each dosage form.
- 5. Labeling shall be based on activity units per recommended daily intake. Where raw material weight or protein amount is also stated, it shall be distinguished in a separate field. Activity introduced during manufacturing shall not be treated as residual activity through the end of shelf life. The business operator shall establish declared values and specifications at release and at the end of shelf life, and shall present their basis together with stability documentation. Units from different test methods shall not be combined without a basis for conversion.
- 6. Lot testing shall include strain origin documentation, enzyme identity, activity, and microbiological control. Substances that may remain from the culture medium, purification agents, drying carriers, or other process sources shall be selected for testing according to risk. Claims of third-party testing shall be based on a certificate of analysis that identifies whether the sample was a raw material or final product, whether identity or activity was tested, the test method used, and the lot concerned.
- 7. Stability evaluation shall confirm changes in residual activity caused by temperature, humidity, light, liquid properties, tableting pressure, granulation, encapsulation, and mixing with other ingredients. Unopened conditions and, where necessary, conditions after opening shall be established for each type of packaging, and storage instructions shall be provided on the label. Information on soybean and other allergens, advice to seek consultation for persons using medicinal products or under medical supervision, instructions to discontinue use in the event of adverse symptoms, and contact methods shall be provided on the basis of official information and product-specific evaluation.
Article 5 (Evaluation Categories)
- Conformity: The production strain, fermentation and purification lots, enzyme identity, activity as defined by the test method, residual activity, and labeling are linked.
- Partial conformity: The strain and activity labeling can be confirmed, but identification of coexisting enzymes or product extraction recovery requires supplementary information, and a corrective action plan is recorded.
- Nonconformity: Raw material weight is stated as activity, test conditions cannot be identified, or labeling during shelf life is supported solely by activity at the time of input.
Article 6 (Implementation)
The business operator may issue a self-declaration of conformity on the basis of strain registers, cultivation and purification records, enzyme identification documentation, activity test procedures, product test results, and stability documentation. Upon application, the Council may verify traceability from the declared units to the test substrate, product lot, and fermentation lot. Reevaluation shall be conducted when the strain, culture medium, fermentation conditions, purification or drying method, carrier, dosage form, or activity test method is changed.
Supplementary Provisions
This Standard shall take effect on 3 September 2026.
※ This Standard sets out evaluation criteria for information disclosure and quality management practices and does not guarantee the efficacy or safety of individual products.