Ginkgo Leaf Extract Quality and Labeling Standard
JHFC-S-008 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)
The composition of ginkgo leaf extract varies with harvest timing, drying, extraction solvents, and refining conditions, even when the plant species and leaf part are the same. The total amount of marker constituents alone does not reveal the distribution of individual constituents or the status of ginkgolic acids requiring control. Extract amount, leaf-equivalent amount, and marker constituent amounts are also distinct concepts. This Standard is established to link plant identification, the actual extraction process, constituent profiles, and testing for characteristic constituents to labeling.
Article 1 (Purpose)
The purpose of this Standard is to evaluate the identity of the plant species and part, leaf collection and extraction provenance, extract form, content of each marker constituent, stability, testing for ginkgolic acids and other substances, and cautionary information for health foods containing ginkgo leaf extract.
Article 2 (Scope)
This Standard applies to oral products formulated with extracts obtained from Ginkgo biloba leaves by solvent extraction and any necessary refining, or with dried or liquid forms of those extracts. Seeds, fruit flesh, branches, and other parts shall not be treated as leaf extract, and leaf powder shall not be labeled as an extract.
Article 3 (Terms and Definitions)
- 1. Ginkgo leaf extract: A fraction obtained by extracting constituents from identified ginkgo leaves and concentrating or drying the extract.
- 2. Extraction ratio: The relationship between the amount of dried leaves used for extraction and the amount of extract obtained.
- 3. Flavonoid glycosides: A group of ginkgo leaf-derived flavonoids evaluated with the measurement conditions before and after hydrolysis specified.
- 4. Terpene lactones: A group of lactones, such as ginkgolides and bilobalide, whose individual constituents are identified and treated separately.
- 5. Ginkgolic acids: A group of alkylphenolic constituents originating from ginkgo.
Article 4 (Requirements)
- 1. The source plant shall be specified by scientific name and the use of the leaf part, and the collection or cultivation area, harvest timing, drying conditions, and lot shall be recorded. Botanical characteristics or genetic information shall be used for unextracted leaves; after extraction, a chemical fingerprint comprising multiple characteristic constituents shall be compared with reference documentation. Plant identity shall not be determined solely by the reaction of a single flavonoid.
- 2. The specification shall state the extraction solvents, such as water or ethanol, the extraction ratio, an outline of refining steps such as concentration and resin treatment, and carriers used during drying. Where the solvent type is declared, its relationship to the entire extraction process shall be clarified. Leaf powder, crude extract, and refined extract shall be distinguished, and the quantity of leaves charged into the process shall not be treated as the final extract quantity.
- 3. Extract identity and consistency shall be evaluated using a constituent profile that includes both flavonoids and terpene lactones. For flavonoids, the form measured and assumptions underlying conversion shall be recorded; for terpene lactones, the breakdown into ginkgolides, bilobalide, and other constituents shall be recorded. Specifications shall be established by the business operator on the basis of authentic reference lots, manufacturing methods, and analytical variability, and their basis shall be presented.
- 4. Content labeling shall state the amount of ginkgo leaf extract per recommended daily intake in units of mass. Where marker constituents are also declared, the target groups, individual constituents, forms measured, and conversion methods shall be specified. Dried leaf-equivalent amount, extract amount, raw material amount including carriers, and marker constituent amounts shall not be confused, and values measured in the final product shall be distinguished from calculated values.
- 5. The quantitative method shall be verified for interference from flavonoids of other plants included in the formulation, sugars, pigments, and other substances. Where hydrolysis is used, the effects of artificial formation or loss on the results shall be confirmed. A method capable of separating individual terpene lactone constituents shall be adopted, and extraction recovery from the product shall be evaluated for each dosage form.
- 6. Stability evaluation shall monitor changes in selected marker constituents, rather than extract amount, in relation to humidity, temperature, light, and the liquid properties of liquid products. Where reactions with other formulation ingredients, moisture absorption, precipitation, or redissolution properties in tablets or liquid products affect the analysis, these factors shall be included in the test conditions. Storage specifications shall be established by the business operator on the basis of documentation for each packaging type.
- 7. Testing shall include plant identity, constituent profiles, constituents subject to labeling, and ginkgolic acids. Pesticides, heavy metals, microorganisms, residual solvents, and other test items shall be selected according to the raw material region and extraction process. For ginkgolic acids, the analyte coverage and limit of quantification of the method used shall be recorded, and specifications and their basis shall be presented by the business operator. For external testing, the stage of the sample in the production process and the lot covered shall be specified.
- 8. Labeling shall consistently indicate that the extract is made from ginkgo leaves, the extract amount, definitions of marker constituents, extraction information, and storage instructions. Advice to seek consultation for persons using medicinal products, persons scheduled for surgery or similar procedures, pregnant or breastfeeding persons, or persons under medical supervision shall be established on the basis of the latest official information and product-specific evaluation. A statement instructing users to discontinue use and make contact in the event of adverse symptoms shall be included.
Article 5 (Evaluation Categories)
- Conformity: Ginkgo leaf identity, extraction steps, constituent profiles covering multiple groups, actual content, and ginkgolic acid control are consistent.
- Partial conformity: Leaf origin and declared constituents can be confirmed, but supplementary documentation is required on the extraction ratio or analytical recovery from the product, and a deadline for action has been established.
- Nonconformity: Leaf powder is labeled as an extract, only aggregate values are provided without showing constituent composition, or ginkgolic acids have not been tested.
Article 6 (Implementation)
The business operator may issue a self-declaration of conformity on the basis of plant receipt records, extraction and refining documentation, chromatograms for individual constituents, product quantification, and stability results. Upon application, the Council may verify traceability from the declared extract to the collected leaves, extraction lot, and ginkgolic acid test records. Reevaluation shall be conducted when the place of origin, harvesting conditions, extraction solvent, refining method, carrier, or analytical 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.