Lutein and Zeaxanthin Quality and Labeling Standard
JHFC-S-014 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)
Lutein and zeaxanthin are carotenoids with closely related structures and occur in free and fatty acid ester forms, as geometric isomers, and as stereoisomers. Other carotenoids and fats and oils coexist in plant extracts, and total carotenoid content, extract amount, and the amounts of individual components are not equivalent. Isomerization and degradation caused by light, oxygen, and heat also affect analytical values. This Standard is established to clarify source materials, chemical forms, component-specific quantification, and stability.
Article 1 (Purpose)
The purpose of this Standard is to evaluate raw material origin, chemical forms and isomers, component-specific content, extraction and formulation processes, changes during analysis, third-party testing, storage, and cautionary labeling for health foods formulated with lutein or zeaxanthin.
Article 2 (Scope)
This Standard applies to raw materials and oral products containing lutein, zeaxanthin, or both in free or ester forms obtained from plants, microorganisms, or other specified origins. Total carotenoids, beta-carotene, or other pigments shall not be treated as lutein or zeaxanthin without component-specific confirmation.
Article 3 (Terms and Definitions)
- 1. Free form: Lutein or zeaxanthin whose hydroxyl groups do not form esters with fatty acids.
- 2. Ester form: A form in which all or some hydroxyl groups are bonded to fatty acids.
- 3. Geometric isomers: Isomers that differ in configuration around double bonds.
- 4. Stereoisomers: Components having the same bonding relationships but differing in spatial arrangement.
- 5. Free-form equivalent amount: An amount expressed on a basis equivalent to the free-form component, taking into account the composition of the ester form.
Article 4 (Requirements)
- 1. Raw material origin shall be recorded for each lot: for plants, the scientific name, part used, cultivation or collection region, and post-harvest treatment; for microorganisms, the species, strain, and cultivation process. Extracted raw materials shall be checked against origin documentation using separation patterns of multiple carotenoids and appropriate spectra or reference substances. Identity shall not be determined solely by color tone or total absorbance.
- 2. Process documentation shall indicate the extraction solvents, whether saponification is performed, purification, crystallization, dispersion in fats and oils, emulsification, encapsulation, and drying carriers. With respect to the stages before and after saponification, whether the release specifications apply to the free form or the ester form shall be identified, and isomerization or oxidation during treatment shall be monitored. Plant powders, extracts, pigment preparations, and purified components shall be distinguished.
- 3. Lutein and zeaxanthin shall be separated, identified, and quantified individually. Where zeaxanthin stereoisomers are declared or specified, the target stereoisomers shall be clearly identified. The treatment of geometric isomers and coexisting carotenoids shall be defined in the analytical procedure. The business operator shall establish composition specifications according to raw material origin and processing method, and shall present their basis together with reference materials and chromatograms.
- 4. Content shall be expressed separately for lutein and zeaxanthin in units of mass per recommended daily intake. Whether the amount represents the free form, ester form, or free-form equivalent amount, the ester composition used for conversion, and whether the amount is measured or calculated shall be clearly stated. Extract weight, preparation weight including fats and oils or carriers, and total carotenoid content shall not be treated as the amounts of individual components.
- 5. Product analysis shall control light, oxygen, temperature, and processing time from sampling through extraction, saponification, concentration, and measurement, and shall evaluate isomerization and degradation during the procedure. Recovery from fats and oils, emulsions, encapsulated materials, tablets, and other dosage forms, and separation selectivity between lutein and zeaxanthin, shall be confirmed. The business operator shall establish acceptance specifications for analytical performance.
- 6. Lot testing shall include source identity, chemical form, component-specific content, and isomer profiles. Test targets shall be selected from pesticides, microorganisms, heavy metals, residual solvents, and other substances, taking into account the cultivation or culture environment and extraction and purification processes. Reasons for exclusions shall also be recorded. For third-party testing, the sample stage, whether saponification was performed, the quantification targets, and correspondence to the lot shall be clearly stated in the certificate of analysis.
- 7. Stability testing shall monitor lutein and zeaxanthin separately and observe changes in isomer distribution and content caused by light, oxygen, heat, moisture, oxidation of the fat or oil base, and formulation ingredients. Light protection, oxygen permeability, and handling after opening shall be linked to packaging specifications, and the business operator shall establish storage specifications. Labeling shall consistently state the origin, chemical form, component-specific amounts, storage instructions, and instructions to discontinue use and seek consultation in the event of adverse symptoms.
Article 5 (Evaluation Categories)
- Conformity: Origin, free and ester forms, isomers, measured amounts of individual components, control of changes during analysis, and storage documentation are consistent.
- Partial conformity: Component-specific labeling can be confirmed, but ester composition or recovery documentation for the preparation is insufficient, and supplementary measures have been established.
- Nonconformity: Total carotenoid content is treated as the amount of each component, conversion is performed without stating the chemical form, or isomerization during analytical procedures is not controlled.
Article 6 (Implementation)
The business operator may issue a self-declaration of conformity on the basis of origin records, extraction and formulation processes, component-specific and isomer-specific analyses, conversion documentation, and storage test results. Upon application, the Council may verify traceability from the declared amount to the chemical form, reference substances, and extraction or culture lot. Reevaluation shall be conducted when the origin, part used or strain, extraction or saponification conditions, base, packaging, 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.