Coenzyme Q10 (Oxidized and Reduced Forms) Quality and Labeling Standard
JHFC-S-003 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)
Coenzyme Q10 occurs in oxidized and reduced forms. Their ratio depends not only on the form at the time of raw material manufacture but may also change through oxidation and reduction during processing, analysis and storage. Labeling only the total amount does not reveal the status of each form, and extraction methods also affect quantification results for formulations incorporating oily bases, inclusion complexation or dispersion processing. This Standard is established to distinguish the oxidized and reduced forms and to enable verification of manufacturing origin, content by form and stability management, including packaging.
Article 1 (Purpose)
The purpose of this Standard is to assess chemical identity, redox form, manufacturing origin, content calculation, recovery from formulations, changes in form during storage, testing and cautionary labeling for health foods containing coenzyme Q10.
Article 2 (Scope)
This Standard applies to raw materials and oral products containing oxidized coenzyme Q10, reduced coenzyme Q10 or both. It includes products formulated by dissolution in oils, emulsification, powdering, inclusion complexation or other formulation processes. Coenzyme Q compounds with different side-chain lengths shall not be included in the amount of coenzyme Q10.
Article 3 (Terms and Definitions)
- 1. Oxidized form: Coenzyme Q10 with a quinone structure.
- 2. Reduced form: Coenzyme Q10 with a quinol structure.
- 3. Content by form: The respective contents determined by separating the oxidized and reduced forms.
- 4. Total CoQ10 amount: The sum of the measured values for each form, with the basis of calculation made clear.
- 5. Interconversion of forms: A change between the oxidized and reduced forms occurring during manufacture, sampling, sample preparation, analysis or storage.
Article 4 (Requirements)
- 1. Raw material identity shall be verified using a reference material that enables identification of the chemical structure and side chain of coenzyme Q10, together with separation analysis and the necessary spectral information. Similar coenzyme Q homologues shall be distinguished, and the identity, assigned value, storage and expiry date of the reference material shall be retained in test records.
- 2. For raw materials, the manufacturing origin, including fermentation, chemical synthesis or other processes, the principal purification processes, and the processes for adjusting the form before shipment as the oxidized or reduced form shall be recorded. Where reduction treatment is performed, its position in the process and the method of control shall be verified using the manufacturing flow diagram and supplier documentation. Where the material is labeled as fermentation-derived, these documents shall verify that fermentation is the process that produces the substance concerned.
- 3. Products labeled as containing the oxidized form shall state the amount of the oxidized form, and products labeled as containing the reduced form shall state the amount of the reduced form, in mass units per recommended daily intake. Where the total CoQ10 amount is also stated, the forms included in the sum and the conversion method shall be disclosed. The ratio of forms at the time of raw material addition shall not be treated as the measured values by form in the finished product. The weight of a raw material formulation containing bases, excipients or encapsulating materials shall be distinguished from the amount of CoQ10.
- 4. Methods for quantification by form shall control oxygen, light, temperature and processing time from sampling through extraction, dilution and measurement, and shall enable interconversion during sample preparation to be determined. Recovery from oils, emulsions or inclusion complexes and the selectivity of separation between the oxidized and reduced forms shall be verified for each formulation. Retention of the reduced form shall not be determined solely by a method measuring total content.
- 5. Stability testing shall monitor both the labeled content by form and the total content, and test conditions shall reflect the light protection of the container, oxygen transmission, atmosphere within the package, presence or absence of individual packaging, and handling after opening. The treatment of conversion to the oxidized form or other degradation in quality assessment shall be determined in advance. The business operator shall establish labeled values and specifications on the basis of data and shall be able to present the supporting rationale.
- 6. Lot testing shall verify identity, content by form, consistency with total content, and related substances anticipated from the manufacturing route. The need to test for residual solvents, catalysts, microorganisms, oxidation of an oily base or similar items shall be determined on the basis of the processes used and the dosage form. Statements concerning third-party testing shall specify whether the test distinguishes forms or measures total content, the stage at which the sample was taken, and the lot concerned.
- 7. On containers and packaging and in sales materials, the terms "oxidized form," "reduced form" and "total amount" shall not be confused, and the same form names shall be used in the ingredient list, content information and summaries of certificates of analysis. Storage instructions shall correspond to stability documentation for the packaging adopted. Guidance on consultation for persons who are pregnant or breastfeeding, taking medicinal products or under medical supervision, instructions to discontinue use if any abnormality occurs after intake, and contact details shall be provided in accordance with the latest information from public authorities and product-specific evaluations.
Article 5 (Assessment Categories)
- Conformity: The CoQ10 homologue and redox forms are identified, and labeling by form, control of interconversion during analysis, and changes during storage correspond with one another.
- Partial conformity: A basis for quantification of the labeled form is available, but supplementary documentation on recovery from the formulation or changes in form after opening is insufficient, and a corrective action plan exists.
- Nonconformity: The amount of the reduced form is claimed solely on the basis of total content, the form present in the raw material is attributed to the finished product, or interconversion caused by analytical procedures is not controlled.
Article 6 (Implementation)
The business operator may make a self-declaration of conformity using origin documentation, specifications by form, analytical method verification, product lot certificates of analysis and stability trends. Upon application, the Council may verify traceability from the labeled form to extraction conditions, chromatograms and packaging conditions. Whenever the raw material form, manufacturing process, base, analytical method or packaging is changed, reassessment shall be conducted for each form.
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.