Fish Oil (EPA and DHA) Quality and Labeling Standard
JHFC-S-002 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)
For fish oil, fatty acid composition and the points requiring control of contaminants vary according to fish species, harvesting waters, parts used and refining processes. EPA and DHA occur in forms such as free fatty acids, ethyl esters and triglycerides, and labeling only the amount of oil or raw material does not identify the actual amount of each constituent. In addition, oxidation caused by oxygen, light and heat may continue after manufacture. This Standard is established to address origin, fatty acid form, separate quantification, oxidation control and contaminant testing as an integrated whole.
Article 1 (Purpose)
The purpose of this Standard is to assess the adequacy of traceability to fish origins, oil forms, content by constituent, oxidative stability, testing appropriate to refining, and cautionary labeling for fish oil products containing EPA or DHA.
Article 2 (Scope)
This Standard applies to capsules, liquid oils, emulsions, powdered oils and other oral products that use oils obtained from fish tissues as raw materials and declare EPA or DHA on their labels. Products derived solely from algal oil, krill oil or oils other than fish oil are excluded; for blended oils, this Standard shall apply to the fish oil portion, which shall be distinguished from the other portions.
Article 3 (Terms and Definitions)
- 1. Fish oil origin information: Fish species, parts used, whether the fish were wild-caught or farmed, the country of origin of the raw material, and the history up to oil manufacture.
- 2. Fatty acid form: The state in which fatty acids occur, including triglycerides, ethyl esters, free fatty acids, phospholipids and other bonding states.
- 3. Separate amounts of EPA and DHA: Values obtained by quantifying EPA and DHA separately and expressing each as a mass.
- 4. Oxidation indicators: Test items adopted by the business operator according to oil characteristics to determine the status of primary oxidation products, secondary oxidation products or both.
- 5. Refining history: The history of processes from crude oil to the raw material used in the product, including degumming, deacidification, deodorization, concentration and other processes.
Article 4 (Requirements)
- 1. For fish oil raw materials, fish species shall be identified by common or scientific name, and the parts used, classification as wild-caught or farmed, harvesting waters or country of origin of the raw material, and crude oil production location shall be recorded for each lot. Where multiple fish species are grouped together, the species group concerned and the method of controlling blending shall be defined. Correspondence with the labeled origin shall be verified using receipt documentation, catch certificates and other supply chain documentation, and species identification methods where necessary.
- 2. The process outline shall state whether refining, concentration, transesterification or re-esterification is performed, and the fatty acid form in the final raw material shall be specified. Where terms such as "natural" or "concentrated" are used, the processes and oil fractions to which they refer shall be delimited. Labeling shall not imply that the properties of fish oil before processing remain unchanged after processing. The form shall be cross-checked against process records and appropriate compositional analyses.
- 3. EPA and DHA shall each be labeled in mass units corresponding to the recommended daily intake. Even where their combined amount is also stated, the separate amounts shall not be omitted, and total fish oil, total omega-3 fatty acids, and EPA and DHA amounts shall not be used interchangeably. It shall be specified whether the amounts refer to the fatty acids themselves or to compounds including esters or other forms, and the equations for converting analytical values to labeled values shall be retained.
- 4. For oxidation control, indicators capable of evaluating primary and secondary oxidation shall be selected according to the characteristics of the raw material oil, oil before filling and the product; assessment shall not rely solely on sensory evaluation. Nitrogen flushing, light-protective containers, antioxidant ingredients, headspace at filling and the period of use after opening shall be linked to packaging specifications. The business operator shall establish specification limits with a supporting rationale, and changes from manufacture through the best-before date shall be verified using stability records.
- 5. Test items shall be selected from heavy metals, PCBs, dioxins and other environmental contaminants, as well as microorganisms or substances originating from refining processes, with regard to the refining history, fish species and harvesting environment. Reasons for excluding items shall also be retained in the risk assessment. Test results shall be verified using certificates of analysis that include the lot concerned, the stage at which the sample was taken, the method, and the limits of quantification and detection.
- 6. The scope presented as third-party testing shall specify which items among separate quantification of EPA and DHA, oxidation indicators and contaminants were actually tested by an external organization. Testing of crude oil by a supplier shall be distinguished from verification of the finished product offered for sale, and links among external certificates of analysis, filling records and product lots shall be maintained.
- 7. Storage labeling shall state the temperature, protection from light and tight closure conditions for unopened products, together with handling instructions where contact with oxygen after opening affects quality, as in liquid products. The presence of fish-derived raw materials shall be identifiable in both the ingredient list and the caution section. Guidance on consultation for persons with fish allergies, persons taking medicinal products and persons scheduled for surgery or similar procedures shall be established in light of product-specific evaluations and the latest information from public authorities. Labeling shall also state that products showing an unusual odor, leakage or container abnormalities shall not be used.
Article 5 (Assessment Categories)
- Conformity: Fish species and supply history, fatty acid form, separate amounts of EPA and DHA, oxidation control and contaminant testing can be verified for each lot.
- Partial conformity: Quantification by constituent and assessment of oxidation are established, but documentation on species groups or labeling for handling after opening requires supplementation, and the measures taken are recorded.
- Nonconformity: Total fish oil is labeled as the amount of EPA and DHA, the fatty acid form cannot be specified, or oxidation or contaminants associated with the origin have not been evaluated.
Article 6 (Implementation)
The business operator may make a self-declaration of conformity using fish oil origin registers, refining and form documentation, fatty acid composition tables, oxidation tests and contaminant certificates of analysis. For products covered by an application, the Council may conduct sample-based verification from the separate content declarations to harvested raw materials and oil processing lots. Reassessment shall be conducted whenever fish species, harvesting waters, refining methods, fatty acid form, packaging or antioxidant design is changed.
Supplementary Provisions
This Standard shall take effect on 3 September 2026.
Note: This Standard provides assessment criteria for information disclosure and quality management practices and does not guarantee the effects, efficacy or safety of individual products.