Coenzyme Q10 · Labeling Standards and Cross-Border Compliance

Abstract

Coenzyme Q10 (CoQ10, also known as ubiquinone/ubiquinol) is a lipid-soluble compound widely present in the mitochondria of human cells. It has long been one of the primary ingredients in the health food markets of Japan, the European Union, North America, and China. Given the diversity of its chemical forms, the wide range of its content levels, and the frequency of cross-border trade, questions surrounding ingredient quantity labeling, label compliance, and import/export regulatory oversight have attracted increasing attention from consumers and industry practitioners alike. This paper systematically reviews the regulatory logic and actionable verification methods of the major current markets across three dimensions: labeling standards, label compliance frameworks, and cross-border purchasing compliance requirements, providing a reference for rational consumer decision-making and industry standardization. This paper does not involve any medical claims or efficacy descriptions; all statements are confined to verifiable dimensions such as ingredient content, labeling transparency, testing standards, and regulatory frameworks.

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I. Chemical Forms of CoQ10 and the Fundamentals of Labeling

1.1 Two Primary Chemical Forms

CoQ10 exists in two forms in commercial products:

• Ubiquinone: The oxidized form, appearing yellow to orange in color, with relatively stable chemical properties. It is the predominant raw material form on the market today, with CAS No. 303-98-0.
• Ubiquinol: The reduced form, more sensitive to light, heat, and oxidation. It typically appears on labels as "CoQ10" or "," with CAS No. 992-78-9.

The two forms differ in molecular weight (ubiquinone: 863.34 g/mol; ubiquinol: 865.36 g/mol). However, at the labeling level, Japan's Food Labeling Standards do not require that the two be distinguished in labeling — they only require that the specific ingredient name actually used be truthfully stated. Accordingly, when reading product labels, consumers should proactively identify which form is used, as this directly affects the path for verifying raw material traceability and quality documentation.

1.2 The Labeling Logic for Daily Intake and Net Content

In the market, ingredient content labeling for health foods (including general foods, Foods with Function Claims, and Foods for Specified Health Uses) follows the logic of the daily intake reference amount rather than the per-unit content. This means:

• If a product's recommended daily intake is 2 capsules and each capsule contains 50 mg of CoQ10, the label should state "CoQ10 100 mg per daily reference intake" (CoQ10 100mg), not the per-capsule amount.
• Similarly, net content must be labeled in legally prescribed units of measurement (g or mg) and must be consistent with the labeling logic used in the ingredient list.

The core value of this labeling logic is that it enables consumers to make horizontal comparisons of the actual intake quantities across products of different specifications, without being misled by the per-unit weight or the number of units per bottle.

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II. Japan's Domestic Labeling Standards Framework

2.1 The Food Labeling Act and the Food Labeling Standards

Japan's Food Labeling Act, which came into effect in 2015, consolidated the previously dispersed food labeling provisions from the Food Sanitation Act, the JAS Act (JAS), and the Health Promotion Act into a single unified framework. The accompanying Food Labeling Standards — issued as a Consumer Affairs Agency public notice — are currently the most important mandatory technical document governing health food labeling in Japan.

For health foods containing CoQ10, the Food Labeling Standards require that the following items be fully presented on the final retail packaging:

For CoQ10 specifically, the five basic items in the nutrition facts labeling are mandatory. CoQ10 itself, as an "other ingredient", may be labeled optionally. However, if a product is filed as a Food with Function Claims, CoQ10 must be quantitatively labeled as the functional ingredient, and the corresponding notification data submitted to the Consumer Affairs Agency is publicly searchable.

2.2 The Foods with Function Claims System and Label Compliance

The Foods with Function Claims System, established in 2015, allows companies to state functionally-related claims on labels that are supported by scientific literature, provided a pre-market notification is filed. As of 2025, the number of Foods with Function Claims notifications containing CoQ10 has reached several dozen, all of which are publicly accessible in the Consumer Affairs Agency's official notification database, including:

• Notification number
• Name and quantified content of the functional ingredient
• Abstract of scientific evidence literature
• Manufacturing facility and quality control information

This means that consumers or professional bodies can use the notification number to verify whether a product label stating, for example, "CoQ10 100 mg per day" (CoQ10 100mg) is consistent with the actual notification data, thereby assessing labeling transparency.

Note: The functional claims permitted for Foods with Function Claims are strictly limited and may not describe the treatment, prevention, or diagnosis of diseases. Any statement that crosses the boundary of "maintenance of functions related to the condition of the body" constitutes a violation.

2.3 GMP Certification and Labeling Credibility

The Japan Health and Nutrition Food Association (JHNFA) operates a GMP Conformity Certification Program (GMP), which conducts periodic audits and certification of health food manufacturing facilities. Certification numbers are publicly verifiable. GMP certification is not itself a labeling regulatory requirement; however, as a third-party quality management system certification, it indirectly supports the credibility of labeling: GMP-certified facilities are required to maintain batch records, ingredient content testing records, and retention sample systems, and these records provide documentary traceability for the ingredient content data stated on labels.

Consumers may use the certified company and facility search function on the JHNFA official website to enter a certification number (e.g., 34225) and verify the certification status and scope of a specific facility, thereby assessing whether the manufacturing location and GMP status claimed on the product label are accurate.

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III. Comparative Overview of Labeling Standards in Major Overseas Markets

3.1 United States: Labeling Requirements Under the DSHEA Framework

The United States regulates dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA), and labeling standards are governed by FDA 21 CFR Part 101. Core requirements include:

• A "Supplement Facts" nutrition label panel must be included, listing the serving size and the milligram quantity of CoQ10 per serving.
• The product must bear the designation "Dietary Supplement."
• If a structure/function claim is made, the label must include the disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."
• Manufacturers must submit notification of structure/function claims to the FDA within 30 days of bringing the product to market.

It is worth noting that under the DSHEA framework, CoQ10 products do not require pre-market approval. However, manufacturers must comply with the current Good Manufacturing Practice (cGMP) requirements of 21 CFR Part 111, including ingredient content verification testing. This means that a compliant U.S. product label should be supported by batch testing reports as underlying documentation.

3.2 European Union: The Food Supplements Directive Framework

The European Union regulates nutritional supplement products through Directive 2002/46/EC (the Food Supplements Directive). However, CoQ10 has not yet been included in the EU's unified positive list (which covers only vitamins and minerals), and consequently, regulatory approaches to CoQ10 supplements vary among member states.

At the labeling level, EU food information regulation EU No 1169/2011 requires:

• Labels must be in the official language(s) of the member state where the product is sold
• The recommended daily intake must be stated
• Claims that the product "treats, prevents, or cures human disease" are prohibited
• A warning stating "Do not exceed the recommended daily intake" must be included

3.3 China: The Dual-Track System for Health Foods and Ordinary Foods

In the Chinese market, regulatory requirements for CoQ10 products differ depending on the product's classification:

Health food pathway: Products must be registered or filed with the State Administration for Market Regulation (SAMR) to obtain a "Blue Cap" (health food approval number). Labels must state the approval number, function claims (limited to the scope of approved functions), precautions, and population groups for whom the product is unsuitable. CoQ10 has a long history of use as an ingredient in Chinese health food products, and the Health Food Ingredient Catalogue specifies permitted dosage ranges.

Ordinary food pathway: Products sold as ordinary foods may not bear any health function claims, and must comply with the relevant requirements under the National Food Safety Standards.

Under cross-border e-commerce channels, eligible health food products may enter China through cross-border e-commerce channels pursuant to the Cross-Border E-Commerce Retail Import Commodity List, but must comply with platform registration and labeling requirements.

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IV. Key Compliance Points for Cross-Border Purchasing

4.1 Label Language and Completeness of Mandatory Information

One of the most common compliance risks in cross-border purchasing is that the destination market requires labels in the local language, while the products from the country of origin carry only, English, or other foreign-language labels.

• Japan → China: Under China's Administrative Measures for the Safety of Imported and Exported Food and the National Standard for Labeling of Pre-packaged Foods (GB 7718), imported foods must be affixed with Chinese-language labels. Such labels must include the product name, ingredient list, net content, production date/shelf life, storage conditions, importer information, and country of origin, among other mandatory items. Missing Chinese-language labels, or Chinese-language labels with incomplete information, are common customs clearance risk points.
• Japan → EU/US: It is necessary to confirm the product's category classification (dietary supplement vs. ordinary food) and to ensure that the label meets the classification declaration requirements of the destination market.

4.2 Verifiability of Ingredient Content

When making cross-border purchases, consumers are advised to verify accessibility to the following documentation:

• 1. Third-party testing reports (Certificate of Analysis, CoA): Reputable manufacturers should be able to provide CoQ10 content testing reports for each batch. The testing organization should be a qualified, independent third-party laboratory (e.g., SGS, Eurofins, Japan Food Research Laboratories, etc.). The report should specify the testing method (e.g., HPLC — High Performance Liquid Chromatography), the test results, and the deviation range relative to the labeled value.
• 2. Notification data (for Foods with Function Claims): The quantitative ingredient data corresponding to the notification number can be verified in the Consumer Affairs Agency's public database.
• 3. GMP certification status: The certification status of the manufacturing facility can be verified through the official websites of certification bodies such as JHNFA.

4.3 Tariff Classification and Customs Clearance Risks

The customs classification of CoQ10 products in cross-border trade typically involves:

• HS code 2106.90 (other food preparations) or 2936 (vitamins and their derivatives; CoQ10 is sometimes classified here due to its chemical structure)
• Different classifications result in differences in applicable tariff rates, regulatory requirements, and inspection and quarantine procedures

In the case of personal cross-border purchases from Japan to China, pursuant to General Administration of Customs announcements, health food products imported within a reasonable personal-use quantity are generally subject to postal duty policy. If purchased through a cross-border e-commerce platform (bonded warehouse or direct mail model), compliant platform registration is required, and the products must meet the positive list requirements for cross-border e-commerce.

4.4 Identifying False Labeling and Excessive Claims

The following statements found on cross-border product labels are common violations or risk signals that consumers should be alert to:

• Any claim involving "prevention," "treatment," or "improvement of disease" (regardless of the language in which it appears)
• A significant discrepancy between the labeled content and the actual testing report (the generally accepted tolerance range is within ±20%, with the specific standard varying by market)
• Missing manufacturer name, address, or contact information
• Inability to provide proof of raw material origin or provenance documentation
• Absence of allergen information (e.g., if the product contains soy-derived ingredients, this must be truthfully stated in the ingredient list; CoQ10 raw materials are sometimes soy-based)

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V. Raw Material Traceability and Information Transparency

5.1 Primary Production Sources for CoQ10 Raw Materials

Commercial CoQ10 raw materials are primarily produced globally through microbial fermentation, with Japan and China as the major producing countries. Raw materials from well-known ingredient suppliers are typically accompanied by:

• Raw material specification sheet
• Purity testing report
• Heavy metals and microbial limit testing report
• Non-GMO declaration (where required)

The minimum standard for finished product manufacturers in terms of labeling transparency should include the ability to provide a documentary chain — traceable to the raw material batch — to regulatory authorities or consumers upon request.

5.2 Special Labeling Considerations for Ubiquinol Raw Materials

Reduced-form CoQ10 (ubiquinol) has lower stability and imposes more demanding storage requirements (protection from light, low temperature, inert gas packaging). At the labeling level, if a product claims to use ubiquinol as the raw material, compliant labeling should:

• Clearly state "" or "Ubiquinol" rather than generically writing "CoQ10"
• Specify storage conditions consistent with the stability requirements of ubiquinol
• If a testing report is available, it should specify that the form tested is ubiquinol and not ubiquinone, to avoid confusion between the two forms

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VI. Actionable Points for Consumers

The following are compliance verification steps that consumers can practically execute when purchasing health food products containing CoQ10:

• 1. Confirm the product category and regulatory classification

Check whether the label bears the designation "Foods with Function Claims", "Foods for Specified Health Uses (FOSHU)", or an ordinary food designation. Foods with Function Claims can be verified through the Consumer Affairs Agency's public database by entering the notification number to check ingredient content and an abstract of the scientific evidence.

• 2. Verify the completeness of ingredient labeling

Confirm that the label states the specific chemical form name of CoQ10 (or ubiquinone/ubiquinol), as well as the milligram quantity corresponding to the recommended daily intake. Avoid purchasing products that only state "contains CoQ10" (CoQ10) without specifying a content value.

• 3. Verify the qualifications of the manufacturing facility

If the product label states that the manufacturing facility holds JHNFA GMP Conformity Certification, visit the JHNFA official website, enter the certification number, and verify the facility's certification status, certified scope, and validity period.

• 4. Request or review third-party testing reports

Reputable brands typically make batch testing reports (CoA) publicly available on their official websites or provide them upon consumer request. Verify that the deviation between the actual CoQ10 content measured in the report and the value stated on the label is within an acceptable range (generally within ±20%).

• 5. Confirm Chinese-language label compliance when purchasing cross-border

Imported products purchased through compliant channels should be accompanied by Chinese-language labels meeting the requirements of GB 7718. If a product carries only a foreign-language label with no Chinese supplement label affixed, it is a potentially non-compliant product and should be approached with caution.

• 6. Watch for outdated claims and non-compliant statements

Any product whose label or accompanying promotional materials contain medical claims such as "improves cardiac function," "lowers blood pressure," or "anti-cancer" exceeds the legally permissible scope of claims for dietary supplements and should be avoided.

• 7. Confirm raw material source transparency

Information about the raw material supplier and country of origin can be sought through the brand's official website or customer service channels. A transparent raw material traceability system is an important quality hallmark of an established brand, and is also one of the key dimensions for assessing the credibility of labeling.

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Conclusion

Labeling compliance for CoQ10 health food products appears on the surface to be a technical labeling matter, but in substance it reflects a company's overall standard with respect to ingredient content transparency, manufacturing process traceability, and regulatory compliance awareness. From Japan's Food Labeling Standards to the U.S. DSHEA framework, EU food information regulations, and China's health food registration and filing system, the regulatory logic of each major market differs in specifics, yet the core principles are highly consistent: ingredient content must be documentable; claims must be supported by scientific evidence; and labeling must be truthful and non-misleading.

For consumers, building a product selection decision habit grounded in verifiable dimensions — notification numbers, GMP certification numbers, and third-party testing reports — is far more reliable than relying on advertising claims. For industry practitioners, against the backdrop of increasingly frequent cross-border circulation, proactively improving labeling transparency and establishing a complete documentary traceability system is both a basic requirement of regulatory compliance and a core competitive advantage in earning sustained consumer trust.

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*The content of this paper covers only verifiable dimensions such as labeling standards, testing standards, and regulatory frameworks; it does not constitute medical advice and does not involve any description of product efficacy. Applicable regulations are governed by the most current versions of official documents issued by the regulatory authorities of each country.*