Vitamin A Quality and Labeling Standard

JHFC-S-026　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)

Vitamin A labeling involves different raw materials: retinol, its fatty acid esters, and provitamin A carotenoids. When deriving a labeled amount from the weight of an oil preparation or a coated powder, confusing raw material concentration with conversion to equivalents can make it impossible to explain the composition even where the numerical values appear to agree. Estimating the amount of vitamin A from color intensity also has limitations. A dedicated evaluation procedure is established to enable purchasers to verify measured values and the basis for conversion for each source.

Article 1 (Purpose)

Retinol-based and carotenoid-based raw materials shall be distinguished, and continuity of calculations and testing from raw material receipt through labeling in equivalents shall be ensured. The five criteria of JHFC-A-001 shall serve as overarching requirements, and this document establishes additional conditions concerning vitamin A forms, degradation control, and labeling documentation.

Article 2 (Scope)

This Standard covers tablets, capsules, oil-based products, and powdered foods that use retinol, retinyl acetate, retinyl palmitate, or substances such as β-carotene as sources of vitamin A. The status of each raw material for food use shall be verified. Products that label only total carotenoids and do not calculate the amount of vitamin A are excluded.

Article 3 (Terms and Definitions)

1. Retinol-based raw material: A raw material for which retinol or its esters form the starting point for the labeled amount.
2. Provitamin A carotenoid: A carotenoid for which a basis has been provided for inclusion in the calculation of vitamin A equivalents.
3. Breakdown by source: A record distinguishing the measured amounts and contributions to equivalents of retinol-based sources and each carotenoid-based source.
4. Coated powder: A preparation made into a powder by retaining an oil-soluble raw material in a carrier or coating.
5. Retinol activity equivalents: The amount of vitamin A expressed using the conversion method of the labeling system adopted.

Article 4 (Requirements)

1. Quality Requirements—Raw Material Identity and Purity

The ester name, carotenoid name, origin, and coating materials shall be stated in the acceptance specifications. Raw materials shall be identified by their separation behavior in comparison with reference standards or by structural documentation, and the concentration of an oil preparation shall be distinguished from the purity of the target compound. For carotenoid mixtures, the components eligible for inclusion in equivalents shall be selected. The business operator shall establish specifications for related substances and shall present the identification results and the basis for those specifications.

2. Quality Requirements—Manufacturing Control

When oil preparations are divided into smaller portions, the amount transferred from the supply container shall be reconciled with the residue on the container walls. For coated powders, the condition of the coating following mixing and tableting, oil exposure caused by milling, and uneven distribution of raw materials used in trace amounts shall be examined. Oil-phase sampling records or test results for powder sampled at different locations shall be linked to manufacturing instructions, and the continued validity of the same formulation calculations after a change in dosage form shall be verified.

3. Testing—Quantification by Form and Third-Party Verification

Separate extraction procedures suitable for retinol-based and carotenoid-based materials shall be used, and recovery and degradation during any necessary saponification shall be verified. Ester species before processing shall not be determined solely from results obtained after saponification. For third-party testing, the product lot, analytes, reference standards, and values before conversion shall be recorded in the certificate of analysis. The testing institution, method, sample stage, and contact point for inquiries shall be disclosed.

4. Labeling Requirements—Equivalents and Sources

The amount of vitamin A per recommended daily intake shall be labeled, and documentation enabling verification of the breakdown by source shall be provided. The mass of β-carotene shall not be transcribed directly as the amount of retinol. Even when units from a foreign certificate of analysis are used, the substances subject to conversion and the basis for the conversion adopted for domestic labeling shall be checked for consistency. Calculations before rounding shall be retained, and it shall be verified that the weight of oil preparations or carriers has not been included.

5. Quality Requirements—Storage and Packaging Materials

Storage test conditions shall include light-protective containers, oxygen contact with the oil phase, and moisture absorption by powder coatings. The remaining amount of the substance subject to labeling shall be measured even in samples with no change in appearance, and carotenoid color alone shall not be used to determine shelf life. The business operator shall establish specifications at the end of shelf life for each type of packaging and shall present their basis. Labeling concerning tight closure after opening and storage location shall correspond to the test conditions.

6. Precautions for Intake

Draft cautionary statements shall be reviewed in light of the raw material form to verify guidance for persons planning pregnancy and pregnant persons. Where β-carotene is included, official cautionary information concerning smoking history shall also be reviewed. Statements shall be included advising users to consider duplicate intake from other vitamin A-containing products and advising persons undergoing treatment or taking medication to consult a physician. The cautionary statements adopted shall be linked to their reference documentation.

7. Documentation Management

Using the calculation sheet for the breakdown by source as the central record, raw material concentrations, coating formulations, test results separated by form, and versions of sales labeling shall be linked. [Documentation on vitamin A forms](https://ods.od.nih.gov/factsheets/VitaminA-HealthProfessional/) and domestic labeling documentation shall be registered with their respective uses distinguished, and conversions from foreign documentation shall not be transferred unconditionally to domestic labeling. The business operator shall establish record retention periods and the scope of recalculation required when corrections are made.

Article 5 (Evaluation Categories)

Conformity: All requirements are met, and calculations from measurements by source to labeling in equivalents can be reproduced.
Partial conformity: The basis for forms, labeled amounts, and cautionary information is secured, and a deadline is set for remedying minor deficiencies, such as those in documentation indexes.
Nonconformity: Carotenoids are converted without identification, the weight of a raw material preparation is treated as an equivalent amount, or testing supporting the labeling is absent.

Article 6 (Implementation)

The self-declaration of conformity shall be accompanied by the combination of sources and dosage form covered. The Council shall verify the equivalent calculations in application documentation by tracing them back to measured values. The scope of the declaration shall be reviewed when switching between retinol-based and carotenoid-based sources or when coating materials or conversion documentation are revised.

Supplementary Provisions

This Standard shall take effect on 7 September 2026. Inquiries shall be directed to the Council and shall specify the vitamin A source and labeling unit.

※ This Standard sets out evaluation criteria for information disclosure and quality management practices and does not guarantee the 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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