Butyrate-Producing Bacteria Quality and Labeling Standard
JHFC-S-017 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)
For raw materials classified as butyrate-producing bacteria, quality assessment depends not only on strain classification but also on the proportions of spores and vegetative cells, germination conditions, and the effects of heat treatment processes. Bacterial counts obtained by culture after heating are not equivalent to the number of spores themselves, the total bacterial cell count, or the amount of butyric acid produced. The means of distinguishing the target bacteria from closely related spore-forming bacteria and the conditions for germinating and recovering spores from formulations also require explicit specification. This Standard is established to evaluate information on strains, life cycles, enumeration involving germination, and processing resistance separately.
Article 1 (Purpose)
The purpose of this Standard is to evaluate strain identification, differentiation between spores, vegetative cells, and dead cells, germination and culture tests, resistance to manufacturing processes, quantity labeling, hygiene testing, storage, and cautionary information for health foods containing butyrate-producing bacteria.
Article 2 (Scope)
This Standard applies to oral products containing spores, vegetative cells, inactivated cells, or combinations thereof, for which the business operator has identified the strains as butyrate-producing bacteria. It does not apply to products containing only butyric acid or other metabolites, or to products that display bacterial counts for fermented materials whose strains cannot be verified.
Article 3 (Terms and Definitions)
- 1. Spore: A resistant cell state formed by a bacterial strain, for which growth following germination can be evaluated under specified conditions.
- 2. Vegetative cell: A cell in a growing state following germination or during cultivation, controlled separately from spores.
- 3. Germination recovery method: A method combining pretreatment, induction of germination, and cultivation to determine the number of culturable spores in a product.
- 4. Processing steps affecting resistance: Heating, drying, granulation, compression, or other processing that may alter bacterial state or recovery rate.
- 5. Confirmation of butyric acid production: Examination of metabolites under specified culture conditions as supplementary information for strain verification.
Article 4 (Requirements)
- 1. The strain used shall be identified by scientifically valid genus and species names, a strain identification code, origin, and preservation history. Genetic or equivalent identification documentation capable of distinguishing the strain from closely related spore-forming bacteria shall be available, and butyric acid production alone shall not serve as the basis for strain identification. The relationship between stock cultures, production seed cultures, and culture lots shall be recorded.
- 2. For cultivation, induction of sporulation, maturation, recovery, washing, drying, and carrier mixing, methods for assessing sporulation and process conditions shall be established. For each raw material lot, the states of spores, vegetative cells, and, where necessary, dead cells shall be determined. The selected means of verification, such as microscopy, staining, heat resistance, or culture methods, and their limitations shall be stated.
- 3. The effects of heating, spray-drying or freeze-drying, granulation, tableting, and product filling on spore survival, germination, and vegetative cells shall be evaluated for each process. Where heat resistance is stated, the applicable cell state and test conditions shall be specified, and results obtained for raw materials shall not be applied unconditionally to different formulation processes. Procedures for segregation and reassessment in the event of process deviations shall be established.
- 4. Quantitative tests shall specify whether heat pretreatment is performed, germination induction conditions, anaerobic conditions, culture media, culture duration, and colony confirmation methods. Methods for determining spore counts shall be distinguished from methods for determining total culturable bacterial counts, and inhibition of germination by product components and recovery losses shall be verified. Where multiple strains or other spore-forming bacteria are present, a confirmation step that distinguishes the target strain shall be incorporated.
- 5. Labeling shall indicate the correspondence between the recommended daily intake or product unit, strain, measurement target such as spores or culturable bacteria, unit, and point in time to which the guarantee applies. The amount of butyric acid, amount of raw material powder, total cell count, and bacterial count introduced during manufacturing shall not be equated with the culturable count of butyrate-producing bacteria. The business operator shall establish specifications for each cell state and shall present the germination recovery method, actual product measurements, and changes during shelf life as the supporting basis.
- 6. For purity and hygiene control, anaerobic bacteria other than the target strain, closely related spore-forming bacteria, and microorganisms that may enter from cultivation and drying environments shall be selected for control according to risk. Where external testing is used, it shall be clearly stated whether identification, spore enumeration, culturable bacterial counts, or hygiene parameters have been verified, and sample pretreatment and the applicable lot shall be recorded in the certificate of analysis.
- 7. Storage tests shall observe changes in spore state and recovered bacterial counts resulting from temperature, moisture, oxygen, packaging, and the potential of the formulation to induce germination. For products in which conversion to liquid form or opening may cause germination or inactivation, conditions during use shall also be evaluated. Labeling shall state cell state, storage conditions and conditions after opening, precautions relating to culture medium or carrier origins, and instructions to discontinue use and seek consultation in the event of abnormalities.
Article 5 (Evaluation Categories)
- Conformity: The strain, sporulation process, assessment by cell state, germination recovery method, processing resistance, and quantity at the end of shelf life can be verified consistently.
- Partial conformity: The strain and culturable bacterial count can be verified, but a supplementary plan is in place for the breakdown of spores and vegetative cells or for formulation-specific germination recovery.
- Nonconformity: The strain is identified solely on the basis of metabolites, spore counts are not distinguished from total bacterial counts, or product labeling is substantiated solely by heat resistance results for the raw material.
Article 6 (Implementation)
The business operator may issue a self-declaration of conformity on the basis of strain registers, sporulation records, tests for each cell state, validation of germination recovery, process resistance documentation, and storage documentation. Upon application, the Council may trace the subject of product labeling back to pretreatment conditions, manufacturing lots, and stock cultures for verification. Reevaluation shall be conducted when the strain, sporulation conditions, drying method, heating process, dosage form, or germination recovery 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.