Bifidobacteria Quality and Labeling Standard
JHFC-S-016 Enacted: 5 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: 5 September 2026 / Effective: the same day
Preamble (Rationale for Enactment)
Bifidobacterial strains differ in their sensitivity to oxygen, nutritional requirements, and culture conditions, and the number of bacteria recovered is susceptible to variation resulting from handling between sampling and measurement. A genus or species name alone cannot identify the strain used in a product, and in products containing multiple strains, the abundance of each strain cannot be determined from the total bacterial count. Furthermore, the total cell count, which includes dead cells, and the viable count of bacteria capable of multiplication are distinct indicators. This Standard is established to verify strain identity, anaerobic handling, strain-specific enumeration, and labeling of cell state at the end of shelf life as an integrated whole.
Article 1 (Purpose)
The purpose of this Standard is to evaluate the validity of strain authenticity, lineage from seed culture to product, oxygen exposure control, differentiation between viable and nonviable cells, bacterial count labeling, testing, and storage information for health foods containing bifidobacteria.
Article 2 (Scope)
This Standard applies to raw materials containing viable cells, inactivated cells, or both, of strains identified as belonging to the genus Bifidobacterium, and to oral products made from such raw materials. It does not cover products in which culture broth, culture supernatant, or fermented substrate alone is labeled quantitatively as bifidobacteria without confirmation of the presence of bacterial cells.
Article 3 (Terms and Definitions)
- 1. Reference strain lineage: The chain of transfers, storage, and passages from stock cultures through seed cultures to production cultures.
- 2. Anaerobic handling: Cultivation, recovery, preparation, packaging, and handling of test samples under conditions that limit oxygen exposure.
- 3. Culturable bacterial count: The quantity of target bacteria whose growth has been confirmed under specified anaerobic conditions and on specified culture media.
- 4. Total cell count: The quantity of bacterial cells detected by the adopted cell detection method, regardless of their ability to multiply.
- 5. Strain-specific recoverability: The extent to which a target strain can be distinguished and quantified in a bacterial mixture or product matrix.
Article 4 (Requirements)
- 1. The raw material specification shall state the genus, species, strain identification code, source of isolation or acquisition, and correspondence with a culture collection or internal culture preservation system. Passage and frozen storage histories from the reference strain to the production seed culture shall be maintained in a register, and identity shall be cross-checked against genetic documentation capable of distinguishing the strain. When a taxonomic name changes, the former name, current name, and supporting documentation for the determination shall be stated together.
- 2. For each stage of seed culture thawing, precultivation, main cultivation, recovery, concentration, freeze-drying, protective agent mixing, and filling, the duration of contact with oxygen, atmosphere, temperature, and holding time shall be recorded in process records. The origins of culture medium components, reducing agents, cryoprotectants, and carriers shall be clarified, and the basis for controlling residual components and allergens shall be provided.
- 3. Viable-cell products shall be controlled on the basis of culturable bacterial counts, and inactivated products shall be controlled on the basis of total cell counts or a bacterial cell indicator defined by the business operator. Values with different measurement bases shall not be added together. Where inactivation treatment is performed, the treatment conditions and the relationship between culture tests before and after treatment and total cell measurements shall be recorded. Claims that a product contains viable bacteria shall be supported by documentation substantiating culturability.
- 4. The test procedure for culturable bacterial counts shall specify anaerobic transport of samples, diluents, selective media, culture atmosphere, culture duration, and colony assessment. The ability to distinguish colonies from those of lactic acid bacteria and other coexisting bacteria in the product shall be confirmed. Where multiple bifidobacterial strains are included, the feasibility of strain-specific measurement, the composition of the total count, and, where estimates are included, the basis of calculation shall be disclosed.
- 5. The labeled quantity shall correspond to the recommended daily intake or a product unit, and the type of indicator, whether viable count, total cell count, or another indicator, and the point in time to which the guarantee applies shall be clearly stated. Certified raw material values or quantities introduced during manufacturing shall not be substituted for final product measurements. The business operator shall establish specifications for each strain or for a reasonably defined bacterial mixture and shall present product recovery tests and changes observed during storage as the supporting basis.
- 6. Lot assessment shall confirm the identity and count of the target strain, contamination by other bacteria, and recoverability from the product. Where genetic detection is used, nucleic acids derived from dead cells and responses from closely related bacteria shall be evaluated, and the resulting values shall not be converted into culturable bacterial counts without validation. A third-party certificate of analysis shall indicate the sample stage, target strain, cell state, test principle, and correspondence with the product lot.
- 7. Stability evaluation shall relate oxygen within the packaging, water activity, temperature, protection from light, desiccants, and coexisting components to product specifications. Repeated exposure during distribution and after opening shall be taken into account, and the labeled indicator at the end of shelf life shall be verified. Storage conditions, handling after opening, strain names, cell states, quantity units, precautions relating to raw material origins, and instructions to discontinue use and seek consultation in the event of abnormalities shall be mutually consistent.
Article 5 (Evaluation Categories)
- Conformity: Strain lineage, anaerobic processes, cell state, the basis for strain-specific or mixed-bacteria enumeration, and labeling at the end of shelf life are traceable.
- Partial conformity: The target strain and labeled quantity can be verified, but supplementary information is required on strain-specific recovery from mixtures or evaluation after opening, and a plan to provide that information is recorded.
- Nonconformity: The strain cannot be distinguished, total cell counts are treated as viable counts, or labeling is substantiated solely by the bacterial count introduced during manufacturing without considering oxygen exposure.
Article 6 (Implementation)
The business operator may issue a self-declaration of conformity on the basis of strain lineage registers, anaerobic process records, tests for each cell state, product recovery documentation, and stability documentation. Upon application, the Council may verify traceability from the labeled value to the product lot, culture lot, and stock culture. Reevaluation shall be conducted when the strain, culture medium, protective agent, drying conditions, formulation, packaging, or enumeration method is changed.
Supplementary Provisions
This Standard shall take effect on 5 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.