Oyster Extract Quality and Labeling Standard

JHFC-S-045　Enacted: 7 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: 7 September 2026 / Effective: the same day

Preamble (Rationale for Enactment)

Oyster extract is a mixture obtained by extracting, concentrating, or drying harvested oysters, and its solids composition varies with the parts used and extraction conditions. Raw material moisture, carrier addition, and enzyme treatment also affect weight labeling. As stating only the amount or number of raw oysters cannot explain the extract amount in the product, this Standard is established to link harvest units with extract mass balances, quality testing, and labeling.

Article 1 (Purpose)

This Standard establishes arrangements for traceability of oyster-derived raw materials and explanation of extract composition, and verifies contaminant transfer during concentration and raw oyster equivalent labeling. The five criteria of JHFC-A-001 shall serve as the prerequisite for information disclosure, and receipt of shellfish raw materials and the classification of extract solids shall be evaluated under this document.

Article 2 (Scope)

This Standard applies to liquid and dried extracts obtained from oyster soft tissues intended for food use through water extraction, enzyme treatment, or similar processes, and foods formulated with such extracts. Whether the entire soft tissue or specific parts are used shall be specified, and the Standard applies to tablets, capsules, beverages, and similar products. Shell powder, minerals obtained from shells, and oyster powder produced without extraction shall be classified separately and shall not be added to the extract amount under this document.

Article 3 (Terms and Definitions)

1. Harvest unit: A traceability unit linking oyster species, sea area, harvest period, and shipment control documentation.
2. Extract solids: The portion of the extract excluding moisture and excluding carriers or seasoning raw materials added subsequently.
3. Raw oyster equivalent conversion: A conversion for labeling that calculates the source amount represented by the extract from the weight or other quantity of oysters used.
4. Composition indicators: Measurement items, such as glycogen, free amino acids, and ash, selected to characterize the condition of the extract.

Article 4 (Requirements)

1. Quality Requirements—Oyster Identity and Receipt

The oyster species, farmed or wild status, harvest sea area, harvest period, and parts used shall be verified. Shucked raw materials shall be traced back to the harvest unit before shell removal, and the thawing and washing history and removal of shell fragments and similar matter shall be checked through receipt records. The business operator shall establish specifications for identity, foreign matter, and raw material condition, and shall present supply documentation and necessary identification tests as supporting evidence.

2. Quality Requirements—Manufacturing Control of Extraction and Concentration

Raw material moisture, extraction water, heating, enzyme types and treatment, filtration, and the course of concentration shall be recorded. The solids mass balance of the extracted liquid and residue shall be examined, and changes in composition indicators associated with enzyme treatment shall be verified. For dried products, the timing and amount of carrier addition shall be fixed. Recontamination after heating shall be included in process control, and records from extraction tanks through drying and filling shall be linked to harvest units.

3. Quality Requirements—Control of Substances Originating from Sea Areas

[Official information on shellfish toxins](https://www.maff.go.jp/j/syouan/tikusui/gyokai/busitu/sizendoku/) and shipment control documentation from the place of origin shall be checked upon receipt. Control items concerning shellfish toxins, elements such as cadmium, and microorganisms and viruses shall be selected on the basis of the sea area and production method. Heating or extraction alone shall not be taken to mean that all items have been addressed. The business operator shall present specifications and their basis, and shall verify transfer into the concentrate using test results.

4. Testing—Extract Indicators and Third-Party Verification

A third-party institution shall be commissioned to test extract composition indicators and contamination items selected according to origin. Where glycogen is declared on the label, sample preparation that distinguishes free sugars and added sugars shall be verified, and total sugar amount alone shall not be used as a substitute. An ash or nitrogen value alone shall not be treated as extract purity. The institution name, method, concentration or drying status of the sample, lot, and contact point for inquiries shall be disclosed, and results before and after extraction shall be made comparable.

5. Labeling Requirements—Solids and Raw Oyster Equivalent Conversion

The oyster extract amount per recommended daily intake shall be stated, together with an indication of whether it is expressed as a liquid raw material equivalent or as extract solids. The weight of dried powder including the carrier shall be stated separately. Where a raw oyster equivalent conversion is declared, whether oysters are shell-on or shucked, whether weights are wet or dry, and the basis for the extraction yield shall be clearly stated; where a number of oysters is stated, evidence of raw material size shall be available. Zinc or other substances added subsequently shall not be included in descriptions of oyster-derived constituents.

6. Storage Requirements—Moisture Absorption and Hygiene of Liquid Products

Storage tests shall verify moisture absorption, clumping, and adhesion to packaging for powders, and sedimentation, container sealing, and microbiological condition for liquid products. Changes in composition indicators and the actual dispensed amount shall also be tracked. The business operator shall establish storage specifications and shelf life for each product and present their basis, and shall reflect storage after opening, keeping utensils clean, and handling in the event of unusual odors or container abnormalities in labeling samples.

7. Precautions for Intake

Precautions for persons with oyster allergies shall be established on the basis of raw material evaluation and shall not be omitted solely because enzymatic degradation or heating has been performed. Users shall not be encouraged to increase or decrease the recommended amount based on the number of oysters stated as a raw oyster equivalent; measuring instructions for the product concerned shall be provided. Labeling shall state that persons undergoing treatment or taking medication shall consult a physician, and draft precautionary text shall be reviewed with consideration of carriers, seasoning raw materials, and added minerals.

8. Documentation Management

Harvest units and shipment control documentation, extraction mass balances, carrier deductions, and raw oyster equivalent calculations shall be retained in a form allowing cross-reference. For manufacture involving materials from multiple sea areas, records shall show which harvest units are represented by the test samples. The business operator shall establish a retention period and shall verify through record comparison that the relevant concentration tanks and packaging lots can be identified when sea area information is updated or an inquiry is received.

Article 5 (Evaluation Categories)

Conformity: All requirements are satisfied, and harvesting, shipment control, concentrate testing, and extract amount labeling can be verified in a continuous chain.
Partial conformity: Origin, contaminant control, and solids calculation are established, and a deadline is set for remedying minor deficiencies such as guidance on calculation documentation.
Nonconformity: Harvest units cannot be traced, control after concentration cannot be explained, or carrier or shell weight is included in extract solids.

Article 6 (Implementation)

The self-declaration of conformity shall include the extraction category and state whether a raw oyster equivalent conversion is used. For the product covered by the application, the Council shall verify the mass balance from harvest documentation through the dried product. The evaluation shall be updated when the sea area, parts used, enzymes, or carriers change, and origin information shall be compared with the testing plan during periodic review.

Supplementary Provisions

This Standard shall be implemented from 7 September 2026. Inquiries concerning raw oyster equivalent conversion shall clearly state how shells and moisture are treated.

※ 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.

This standard is an evaluation standard on information disclosure and quality management; it does not guarantee the efficacy or safety of any individual product. Businesses may make a self-declaration of conformity based on this standard, and the Council confirms declarations upon application.

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