Squalene Quality and Labeling Standard
JHFC-S-007 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)
Squalene is obtained from different origins, including marine organisms, vegetable oils, and fermentation, and raw material oils contain coexisting hydrocarbons, lipids, and trace constituents that differ according to origin. Squalene is highly unsaturated and may undergo changes caused by oxygen, light, and heat even after refining. Furthermore, squalane, which has a similar name, is a distinct hydrogenated substance. This Standard is established to clarify the distinction between these two substances, origin, actual content in oil, oxidation control, and testing according to origin.
Article 1 (Purpose)
The purpose of this Standard is to evaluate chemical identity, raw material origin and refining history, distinction from squalane, content labeling, stability in oil and fat formulations, impurity testing, and cautionary statements appropriate to origin for health foods containing squalene.
Article 2 (Scope)
This Standard applies to squalene raw materials of animal, plant, microbial, or other origin and to oral products containing them, such as liquid oils, soft capsules, emulsions, and powdered oils and fats. Products containing only squalane are excluded. Where both substances are present, they shall be controlled separately.
Article 3 (Terms and Definitions)
- 1. Squalene: A specific triterpene hydrocarbon having multiple carbon-carbon double bonds.
- 2. Squalane: A saturated hydrocarbon obtained by hydrogenation of squalene, which shall be treated separately from squalene.
- 3. Source oil: An oil or fat of animal or plant origin before squalene is separated or concentrated.
- 4. Refining history: The processing steps from the source raw material to the squalene raw material, including extraction, deodorization, distillation, fractionation, concentration, and other steps.
- 5. Hydrocarbon composition: Compositional information that distinguishes squalene, squalane, and other hydrocarbons.
Article 4 (Requirements)
- 1. Identity shall be confirmed by combining retention behavior relative to a reference substance with mass spectra, infrared spectra, or other structural information, and separation from squalane and similar hydrocarbons shall be demonstrated. Squalene shall not be identified solely by an overall measure of unsaturation such as the iodine value. Control records for reference substances and analytical test solutions shall be retained.
- 2. For animal origins, the species, tissue used, collection area, and history through crude oil production shall be recorded. For plant origins, the plant species, part used, raw material oil, and oil extraction method shall be recorded. For fermentation and similar origins, the identity of the organism used, substrate, and recovery steps shall be specified. Where origins are mixed, the proportions from each origin shall be controlled, and labeling shall not imply a single origin.
- 3. The process flow diagram shall indicate whether extraction, molecular distillation, deodorization, decolorization, concentration, or hydrogenation steps are present. Where squalane is produced as a co-product or handled in the same equipment, control points for conversion and cross-contamination shall be established. Lot documentation shall distinguish the name of the source oil, the refined squalene raw material, and the oil or fat base in the product.
- 4. Content shall be declared in units of mass of squalene itself corresponding to the recommended daily intake. The amount of raw material oil, refined oil, or soft capsule contents shall not be treated as the amount of squalene. Where squalane or other substances are present, they shall be quantified separately, and amounts calculated from raw material specifications shall be distinguished from amounts measured in the final product. Declared values and control ranges shall be established by the business operator on an analytical basis.
- 5. In stability evaluation, in addition to squalene content, items capable of assessing primary and secondary oxidation states, as well as off-odors, color, and other characteristics, shall be selected according to the formulation characteristics. Protection from light, oxygen transmission through the container, the atmosphere within the sealed package, antioxidant measures, headspace, and exposure conditions after opening shall be reflected in the test plan. Squalene depletion and oxidation of the total oils and fats shall be recorded separately.
- 6. Lot testing shall include squalene identity, quantification, hydrocarbon composition, and oxidation-related items. Environmental contaminants for marine origins, pesticides and similar substances for plant origins, and microorganisms and process-derived substances for fermentation origins shall be considered as candidate test items. Test items shall be determined through risk assessment that includes the removal capability of refining. Residual solvents shall also be addressed according to the actual process, and specifications shall be presented by the business operator together with their basis.
- 7. Labeling shall clearly distinguish the terms "squalene" and "squalane," and the origin category, measured squalene content, oils and fats included in the formulation, and storage instructions shall correspond to the same product specification. Allergens and other matters requiring declaration arising from the animal or plant species shall be evaluated. Guidance for persons using medicinal products, pregnant or breastfeeding persons, or persons under medical supervision, and instructions to discontinue use in the event of adverse symptoms, shall be established in accordance with official information and individual evaluation.
Article 5 (Evaluation Categories)
- Conformity: Squalene is distinguished from squalane, and origin, refining steps, actual content, changes in oxidation over time, and testing according to origin are consistently linked for each lot.
- Partial conformity: Identity and content are established, but part of the source oil history or documentation on oxidation after opening is insufficient, and supplementary measures are recorded.
- Nonconformity: Squalane is treated as squalene, raw material oil quantity is declared as squalene content, or assessment of oxidation state and testing according to origin have not been established.
Article 6 (Implementation)
The business operator may issue a self-declaration of conformity on the basis of evidence of origin, refining flow diagrams, hydrocarbon composition, product quantification, and oxidative stability documentation. Upon application, the Council may verify traceability from the declared squalene to the source oil and the separation and filling lots. Reevaluation shall be conducted when the species, part collected, manufacturing method, oil or fat base, packaging, or test 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.