Equol Quality and Labeling Standard
JHFC-S-050 Enacted: 8 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: 8 September 2026 / Effective: the same day
Preamble (Rationale for Enactment)
Equol is a constituent for which stereochemical configuration is specified, and the weight of a fermented raw material or the total measured equol value alone cannot establish the amount of the labeled form. Soy-derived constituents used in fermentation and unconverted substrates also need to remain in the description of the final raw material. This Standard is established to substantiate the amount actually present in food through records of raw material production and testing that distinguishes isomers.
Article 1 (Purpose)
This Standard establishes evidence that can be cross-checked concerning the stereochemical configuration of equol, its production route, and its content in products. Based on JHFC-A-001, which provides the overarching requirements for information disclosure, this document clarifies the distinction between the amount of fermented material and the amount of the specified isomer.
Article 2 (Scope)
Products Covered
This Standard applies to equol raw materials whose food use and stereochemical configuration have been verified, and to powders, tablets, capsules, and liquid foods containing them. Materials incorporated as fermented material shall be distinguished from those that have been separated and purified. Amounts assumed to be produced after ingestion from daidzein or similar constituents in the raw material shall not be included in product content.
Article 3 (Terms and Definitions)
- 1. Specified isomer: The stereochemical configuration of equol identified in the product specifications as the S-form, R-form, or another designation.
- 2. Quantification by isomer: Analysis that determines the amount of each stereochemical form by separating or distinguishing the forms.
- 3. Unconverted substrate: A starting constituent, such as daidzein, that remains after the production process has ended.
- 4. Dry weight of fermented material: The dry weight of fermented material, including residual substrates and other substances apart from equol.
Article 4 (Requirements)
1. Quality Requirements—Evidence of Stereochemical Configuration
Identification of equol itself and verification of the specified isomer shall be established as separate items. The analytical principles of quantification by isomer using reference samples shall be compared with sources such as the [report on stereoselective production and separation](https://pubmed.ncbi.nlm.nih.gov/15640190/). The business operator shall establish specifications for isomer composition, unconverted substrates, and related products of the process, and shall provide the rationale for those specifications using structural documentation and results.
2. Quality Requirements—Manufacturing Control at the End of Fermentation
The microbial strain, substrate, culture medium, and culture conditions used shall be identified. Process completion shall not be determined solely by substrate consumption; the amount of equol produced shall be verified. The process sheet shall state whether microbial cells are retained or removed, whether heat treatment is performed, and the holding conditions until drying. For purified products, recovered and discarded fractions shall be traced. Where a synthetic route is used, records verifying residual starting materials shall also be maintained.
3. Testing—Reconciliation of Total Amount and Specified Isomer Amount
The equol amount shall be measured by a third-party institution, and where a stereochemical designation is labeled, the breakdown shall be verified by chiral separation or a comparable method. For samples containing fermented material, interference from daidzein and adjacent peaks shall be evaluated. Where the specified isomer amount is calculated from the total amount, the ratio used shall be determined from the same sample lot. The institution name, analytical method, classification as raw material or product, lot, and contact point for inquiries shall be disclosed.
4. Labeling Requirements—Distinguishing Equol from Fermented Material Amounts
The equol amount per recommended daily intake and the isomer designation shall be clearly stated. Total equol content shall not be transcribed into a field stating the S-form amount. Where the dry weight of fermented material or the soy isoflavone amount is also stated, each shall be presented as a separate item and shall not be added to the equol amount. Labeled values shall be reconciled using the final formulation, raw material results, and product testing.
5. Quality Requirements—Accompanying Substances in Fermented Raw Materials
Residual proteins originating from substrates such as soybeans, culture medium constituents, microorganisms, and purification solvents shall be investigated by production method. The business operator shall establish specifications and testing frequencies for each item and shall also present reasons for any omitted items. The handling of microbial cells after fermentation shall be verified through the certificate of analysis, and labeling that claims the presence of viable microorganisms shall not be adopted solely on the basis of the name of the fermented material.
6. Quality Requirements—Maintenance of Content during Mixing and Storage
For powders with a low formulation level of equol, premixing and the sequence of portioning shall be recorded, and equol content shall be tested at different positions in the portion-packaging sequence. For liquid products, recovery shall be verified for both precipitated material and the liquid phase. The business operator shall establish storage specifications for content, isomer composition, and microorganisms, and shall determine labeling conditions such as shelf life, protection from light, and tight closure from tests using the actual packaging.
7. Precautions for Intake
Users shall be advised to check the specified isomer amount and recommended daily intake when using other equol-containing products concurrently. For fermented raw materials using soybeans, allergy cautionary statements shall be reviewed in accordance with ingredient information. A statement advising persons undergoing treatment or taking medication to consult a physician shall be provided, and information on substrates and auxiliary ingredients shall be available for presentation during such consultation.
8. Documentation Management
The correspondence between microbial strains and substrates, assessment of culture completion, analysis of unconverted substrates, and results by isomer shall be linked by production lot. The stereochemical designation and purity certification of analytical reference standards shall be retained, and the business operator shall establish a retention period. When the formulation proportion of fermented material changes, records of separate recalculations of the equol amount and soy constituent amounts shall be retained.
Article 5 (Evaluation Categories)
- Conformity: All requirements are addressed, and the production route, specified isomer, and measured amount in the food are consistent.
- Partial conformity: Assessment of the isomer and content is complete, and a deadline for supplementation is set for minor deficiencies such as documentation links.
- Nonconformity: The total amount is treated as the specified isomer amount, fermented material weight is treated as constituent amount, or an amount assumed to be produced after ingestion is included in labeled content.
Article 6 (Implementation)
The self-declaration of conformity shall state the isomer designation and classification as fermented material or purified product. The Council shall verify the production records and stereochemical analysis for the product covered by the application. Reverification shall be performed when the microbial strain, substrate, purification fraction, or chiral measurement conditions change, and periodic review shall examine labeling of the specified amount.
Supplementary Provisions
This document shall take effect on 8 September 2026. Documentation for inquiries concerning isomers shall be presented separately from documentation concerning the total amount.
※ This Standard sets out evaluation criteria for information disclosure and quality management practices and does not guarantee the effects, efficacy, or safety of individual products.