Lactic Acid Bacteria Quality and Labeling Standard
JHFC-S-015 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)
Lactic acid bacteria products may contain different strains even when the species name is the same, and the state of viable cells changes according to cultivation, concentration, drying, and storage conditions. Furthermore, the meaning of the quantities to be declared and the methods for verifying them differ for viable cells, heat-treated cells, and cell components. Culture units, raw material powder amount, and bacterial counts in the final product are also not identical, and taxonomic names may be revised. This Standard is established to clarify strain identity, cell state, enumeration methods, and the basis for labeling at the end of shelf life.
Article 1 (Purpose)
The purpose of this Standard is to evaluate strain identification, cultivation and recovery processes, classification as viable or treated cells, labeling of bacterial counts and cell amounts, microbiological quality, storage, third-party testing, and cautionary information for health foods containing lactic acid bacteria.
Article 2 (Scope)
This Standard applies to viable cells, heat-treated cells, dried cells, or oral products formulated with these cells, from bacteria regarded as producing lactic acid as a principal metabolite and for which the business operator has identified the genus, species, and strain. Fermented foods themselves, culture supernatants alone, or metabolites alone shall not be labeled as lactic acid bacteria counts without confirmation of the presence of bacterial cells.
Article 3 (Terms and Definitions)
- 1. Strain: A microbial lineage distinguished from other strains by its origin, identification code, and preservation history.
- 2. Viable cells: Bacterial cells whose ability to multiply is confirmed through colony formation or other means under specified culture conditions.
- 3. Treated cells: Bacterial cells subjected to heat or other treatment and controlled on a measurement basis different from that used for viable cells.
- 4. Bacterial count labeling: A quantity stated in relation to the recommended daily intake or a product unit, specifying the measurement method and cell state.
- 5. End-of-shelf-life guarantee: Documentary confirmation of correspondence with the established bacterial count specifications under the labeled storage conditions and within the labeled shelf life.
Article 4 (Requirements)
- 1. The genus, species, and strain identification code of the bacteria used shall be stated in the raw material specification, and the source of strain isolation or acquisition, stock cultures, working cultures, and passage history shall be traceable. Identity shall be confirmed using genetic methods capable of distinguishing the strain, or equivalent documentation, in addition to phenotype. Where a taxonomic name is revised, its correspondence to the former name and the basis for adopting the revised name shall be subject to version control.
- 2. Each step of seed cultivation, main cultivation, culture medium use, recovery, washing, concentration, freezing or drying, protective agent addition, and mixing shall be linked to lot records. Allergens and residual components originating from culture media and protective agents shall be evaluated. For viable-cell products, oxygen, moisture, temperature, and other inactivation factors shall be controlled. For treated cells, treatment conditions and the state after treatment shall be controlled.
- 3. Viable cells, heat-treated cells, and mixtures of the two shall be clearly distinguished. Viable counts shall be measured using a method specifying the culture medium, culture atmosphere, temperature, time, and criteria for identifying colonies. For mixtures of multiple strains, whether strain-specific enumeration is possible and the calculation method shall be stated. For treated cells, the selected measure, such as total cell count or dry weight, shall be defined, and treated cells shall not be added to viable counts as if they were expressed in the same units.
- 4. Labeling shall clearly indicate the relationship to the recommended daily intake or product unit and shall state the strain name, cell state, measurement unit, and whether the guarantee applies at manufacture or at the end of shelf life. The bacterial count introduced as raw material shall not be treated as a measured value for the final product, and variations due to recovery, mixing, and filling shall be reflected. The business operator shall establish specifications for bacterial counts or cell amounts and shall present test methods and stability documentation as their basis.
- 5. Final product testing shall confirm the effects of coexisting strains, microorganisms originating from the product, and nonculturable cells on measurement. Where selective media are used, recovery of the target strain and exclusion of nontarget microorganisms shall be verified. Gene quantities shall not be directly converted to viable counts. Methods for recovering bacterial cells from solid, oily, acidic, and other formulations shall be established for each dosage form.
- 6. For microbiological quality, the business operator shall establish control items for microorganisms other than the intended bacteria, strain purity, and hygiene conditions in the manufacturing environment according to raw material characteristics and processes. Procedures for identification, segregation, and release decisions where contamination is suspected shall be recorded. For third-party testing, the scope of strain identification, bacterial count, or hygiene parameters, sample stage, method, and lot concerned shall be clarified in the certificate of analysis.
- 7. Storage testing shall take into account temperature, humidity, oxygen, light, and the moisture resistance and seal integrity of packaging. For viable-cell products, changes in viable counts through the end of shelf life shall be observed. For treated cells, changes in the selected quality indicators shall be observed. Handling conditions shall be established for products affected by moisture absorption after opening or repeated opening. Labeling shall state storage temperature, handling after opening, allergens, explanations that prevent misunderstanding as to cell states not covered by the product, and instructions to discontinue use and seek consultation in the event of adverse symptoms.
Article 5 (Evaluation Categories)
- Conformity: Strain identity, cultivation lots, cell state, measurement methods, the basis for quantities at the end of shelf life, hygiene control, and storage labeling are consistent.
- Partial conformity: The strain and quantity labeling can be confirmed, but strain-specific enumeration or documentation for conditions after opening is insufficient, and the method and deadline for supplementing the missing information are recorded.
- Nonconformity: The strain is not identified, viable and treated cells are combined on the same basis, or labeling at the end of shelf life is supported solely by the bacterial count introduced during manufacturing.
Article 6 (Implementation)
The business operator may issue a self-declaration of conformity on the basis of strain registers, cultivation and processing records, cell state assessments, product enumeration, hygiene testing, and changes observed during storage. Upon application, the Council may verify traceability from the declared bacterial count to the measurement conditions, product lot, working culture, and stock culture. Reevaluation shall be conducted when the strain, culture medium, treatment conditions, protective agent, dosage form, packaging, storage conditions, or measurement 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.