Vitamin E Quality and Labeling Standard
JHFC-S-023 Enacted: 6 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: 6 September 2026 / Effective: the same day
Preamble (Rationale for Enactment)
Vitamin E raw materials differ in their stereoisomer composition according to natural or synthetic origin, in whether they are in free or esterified form, and in their tocopherol homolog composition. Confusion between the labeling bases for total raw material amount, alpha-tocopherol amount, and biological potency impairs comparability. In fats and oils, oxygen, light, heat, and the condition of coexisting lipids also affect the amount remaining. This Standard is established to clarify stereochemistry, homologs, ester conversion, and oxidative stability.
Article 1 (Purpose)
The purpose of this Standard is to evaluate natural or synthetic origin, stereoisomer and homolog composition, potency calculation, processes involving fats and oils, separate quantification, storage, and labeling information for health foods containing vitamin E.
Article 2 (Scope)
This Standard applies to oral products made with alpha-tocopherol, its esters, mixed tocopherols, or other sources of vitamin E. Where tocopherols used for antioxidant purposes coexist with vitamin E whose content is labeled as a nutrient, each use and the basis for its amount shall be distinguished.
Article 3 (Terms and Definitions)
- 1. Natural form: A naturally derived tocopherol form for which the raw material origin and stereochemical configuration have been verified.
- 2. Synthetic form: A tocopherol form derived from chemical synthesis that may contain multiple stereoisomers.
- 3. Esterified form: A raw material form in which the hydroxyl group of alpha-tocopherol is bonded to an organic acid.
- 4. Homolog composition: The composition showing tocopherols such as alpha, beta, gamma, and delta separately.
- 5. Vitamin E potency: The value treated as the vitamin E amount subject to labeling on the basis of the form and the conversion basis under the regulatory system.
Article 4 (Requirements)
- 1. Raw material specifications shall state whether the material is naturally or synthetically derived, its origin, chemical name, whether it is in free or esterified form, stereoisomer designation, and homolog composition. Identification shall be performed using optical rotation, chromatography, agreement with reference standards, or other appropriate documentation, and natural and synthetic forms shall not be treated as having the same potency without supporting grounds. The business operator shall establish specifications by isomer and homolog.
- 2. Where an esterified form is converted to a free alpha-tocopherol equivalent amount, calculation sheets shall reflect molecular composition, raw material purity, moisture content, and preparation concentration. Where international units or other potency units are used, the conversion basis for each applicable form and its relationship to the labeling units under the regulatory system shall be clearly stated. Total tocopherol amounts in raw materials and amounts subject to labeling shall be controlled separately.
- 3. Temperature, oxygen exposure, light, contact metals, and holding time shall be recorded for refining of extracted oils, esterification, distillation, concentration, dissolution in fats and oils, emulsification, and filling. For naturally derived raw materials, the source fats and oils and refining history shall be traced; for synthetic raw materials, processes affecting isomer composition shall be traced. Lot acceptance decisions for products containing combinations of fats and oils shall include the oxidation state of the base oil.
- 4. The quantitative method shall allow separation of free and esterified forms and individual tocopherol homologs according to the purpose. Where saponification or hydrolysis is performed, the conversion rate, prevention of oxidation during analysis, and recovery shall be validated, and the components included in the total amount shall be listed in the certificate of analysis. Third-party testing shall clearly state whether stereoisomers can be distinguished, the sample form, analytical targets, and potency conversion.
- 5. Stability evaluation shall examine container light protection and oxygen permeability, headspace, repeated opening, temperature, and oxidation of coexisting unsaturated lipids. For powdered or emulsified products, the effects of carriers, coatings, and moisture shall be observed; for oily products, the relationship between the progress of peroxidation and the remaining amount of vitamin E shall be observed. The business operator shall establish specifications at the end of shelf life and shall present documentation for each packaging specification.
- 6. Content labeling shall state the vitamin E amount corresponding to the recommended daily intake or a product unit and shall clarify whether the amount represents alpha-tocopherol equivalents, total tocopherols, or individual homologs. Where the product is labeled as a food with nutrient function claims, the adopted labeling unit, components included in the calculation, recommended intake, and prescribed labeling particulars shall be verified against regulatory documentation applicable at the time of application.
- 7. Intake labeling shall provide guidance on avoiding duplicate and excessive intake through concurrent use of other products containing vitamin E. Persons using medicines, undergoing treatment, or otherwise requiring individual verification shall be encouraged to seek prior consultation, and instructions to discontinue use in the event of adverse changes in physical condition and information on whom to consult shall be provided. The basis for the precautions and recommended intake shall be retained in the product documentation.
Article 5 (Evaluation Categories)
- Conformity: Origin, stereoisomers, homologs, ester conversion, oxidation control of fats and oils, amounts at the end of shelf life, and regulatory labeling can be explained consistently.
- Partial conformity: The amount subject to labeling can be verified, but supplementary information is needed on homolog separation or the condition of fats and oils after opening, and arrangements for providing that information are recorded.
- Nonconformity: Natural and synthetic forms are not distinguished, total tocopherols are treated as labeled potency without supporting grounds, or ester weight is treated as the vitamin E amount without conversion.
Article 6 (Implementation)
The business operator may issue a self-declaration of conformity on the basis of documentation on origin and stereochemistry, homolog test results, potency conversion sheets, records of processes involving fats and oils, and stability tests. Upon application, the Council may verify traceability from the amount subject to labeling to the product lot, individual homologs, and raw material processes. Reevaluation shall be conducted when the origin, isomer composition, ester, base oil, packaging, or measurement method is changed.
Supplementary Provisions
This Standard shall take effect on 6 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.