Collagen · Labeling Standards and Cross-Border Compliance

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Abstract

Collagen is one of the best-selling ingredients in health food globally, and the market stands at the forefront in product development, ingredient standardization, and the establishment of compliance frameworks for this category. However, due to substantive differences in regulatory frameworks for health foods across countries, compounded by the growing prevalence of cross-border purchasing through e-commerce platforms, consumers face a high information barrier when it comes to interpreting product labeling, understanding ingredient quantity declarations, and identifying compliance marks. This paper systematically reviews the current rules in Japan and relevant markets across three dimensions — ingredient quantity labeling standards, label compliance requirements, and cross-border purchasing compliance considerations — with the aim of providing consumers with an objective, actionable reference framework.

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I. Regulatory Classification of Collagen Health Foods

1.1 Legal Framework in Japan

In Japan, the overwhelming majority of oral products containing collagen circulate as food products, subject to the combined regulatory regime of the Food Sanitation Act, the Health Promotion Act, and the Act Against Unjustifiable Premiums and Misleading Representations.

The Ministry of Health, Labour and Welfare (MHLW) and the Consumer Affairs Agency (CAA) are the primary regulatory authorities. If a product is designated as a "Functionally Labeled Food", the manufacturer must submit a notification dossier to the CAA in advance, including a systematic literature review (SR) or randomized controlled trial (RCT) results, and must include on the label a statement to the effect that "this labeling is made under the responsibility of the business operator." Products sold solely as ordinary food or nutritional supplements may not include on their labels or in their advertising any language implying the prevention or amelioration of disease.

Core boundary: Regardless of category, oral collagen products may not claim therapeutic, diagnostic, or preventive effects on disease. To do so would constitute a violation of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.

1.2 Comparison with China's Regulatory Framework

China applies a dual-track system of "registration and filing" for health foods, requiring the Blue Cap certification mark issued by the State Administration for Market Regulation (SAMR) before a product may be sold as a health food within China. Products that possess only a domestic sales qualification without having undergone Chinese registration or filing, but are marketed or sold within China under the designation "health food," are in violation of regulations. Ordinary food imports must comply with China's National Food Safety Standards, with constraints on ingredient quantities and types of additives; regulatory compliance does not equate to Chinese regulatory compliance.

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II. Ingredient Quantity Labeling Standards for Collagen Products

2.1 Labeling Distinctions Between "Collagen Peptide" and "Collagen"

Raw material forms for collagen products on the market are primarily divided into three categories:

Japan currently has no mandatory national standard specifying a molecular weight range for "collagen peptides"; however, industry bodies such as the Japan Gelatin & Collagen Industrial Association have issued voluntary guidelines requiring that products claiming a specific molecular weight must be supported by verifiable test data. When making a purchase, consumers may check whether the product discloses specific molecular weight values and the corresponding testing methodology.

2.2 Labeling Requirements for Daily Intake and Ingredient Quantities

Under the CAA's Food Labeling Standards (in force since 2015, as subsequently amended), labels for processed foods must indicate the serving size (1) and the daily intake guideline (1), with the content of principal ingredients listed accordingly.

For Functionally Labeled Foods, the CAA further requires:

• Functional ingredients must be labeled with their content expressed per daily intake quantity; labeling the total weight alone is not permitted.
• If a functional claim concerns a specific peptide sequence (e.g., Pro-Hyp, Gly-Pro), the notification dossier must explain the actual content of that sequence in the finished product and the analytical method used.
• Labels must include "" (precautions for consumption), including the recommended daily upper intake limit.

Consumer identification points: If a product merely states "collagen × grams per serving" without breaking down the specific peptide forms and molecular weights, the level of information transparency is low. Products that disclose an amino acid score or cite the source of a peptide content test report carry comparatively higher informational reliability.

2.3 Labeling of Raw Material Origin and Source Animal

The primary raw material sources for collagen are pigskin, bovine hide/bone, and fish scales/skin. Japan's Food Labeling Standards impose disclosure obligations regarding the country of origin of raw materials, though the specific requirements vary by product category:

• Fresh foods: Mandatory declaration of country of origin.
• Processed foods (including health foods): As a general rule, the country of origin of the raw material with the highest proportion by weight must be declared; the 2022 revisions tightened the disclosure obligation for processed foods that use imported raw materials.
• Source animal: For consumers with religious dietary restrictions (e.g., Muslims, Jews, vegetarians), information on the source animal is critically important. Some products additionally carry Halal certification or a notation such as "" (fish-derived), though this is not currently mandatory.

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III. Core Elements of Label Compliance

3.1 Types of Prohibited Claims

Under the Act Against Unjustifiable Premiums and Misleading Representations and the CAA's Guidelines on Health Food Advertising, the following types of claims constitute violations or fall within a high-risk zone:

• Therapeutic-effect language: Such as "improves skin elasticity," "treats joint pain," or "prevents osteoporosis" — all of which exceed the permissible scope of food labeling.
• Absolute or superlative claims: Such as "most effective" or "100% absorbed" — these require substantial scientific substantiation; without it, they constitute misleadingly superior representations.
• Before-and-after comparison images: If imagery implies physical changes attributable to consumption of the product, the label must include a disclaimer stating "" (individual results may vary) and must be supported by substantive evidence.
• Physician/expert endorsements: The endorsement must clearly state that its scope is limited to nutritional ingredient information and does not constitute medical advice.

3.2 Mandatory Statutory Labeling Items

Under the Food Labeling Standards, mandatory items on processed food labels include:

• 1. Name (product name)
• 2. Ingredient name (including additives, listed in descending order by weight)
• 3. Net content
• 4. Best-before date or use-by date
• 5. Storage instructions
• 6. Name and address of the manufacturer
• 7. Nutrition facts panel (the five mandatory items are: energy, protein, fat, carbohydrates, and sodium equivalent)
• 8. Directions for use and daily intake guideline

3.3 GMP Certification and Third-Party Testing

The Japan Health and Nutrition Food Association (JHNFA) operates a GMP Compliance Certification program, which audits and certifies factories on raw material management, manufacturing processes, finished product testing, and shipment control. The certification number (e.g., 34225) is a publicly verifiable identifier. A factory holding this certification has had its manufacturing processes reviewed by a third party and provides a certain degree of traceability assurance; however, the certification itself does not constitute an endorsement of any product's claimed efficacy.

Consumers may visit the JHNFA's official website to verify whether a given certification number is valid and whether the corresponding factory information is consistent. This is the most direct method for verifying a product's manufacturing compliance.

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IV. Cross-Border Purchasing Compliance Considerations

4.1 Quantity Limits for Personal Carry-On and Mail Import

Under customs regulations, health foods imported for personal use — whether carried in person or purchased through personal mail order — are exempt from duty on amounts with a total retail value of up to 200,000 yen (certain categories were adjusted following the 2024 revisions), provided the quantity constitutes a "reasonable amount for personal use." Quantities exceeding this threshold, or cases where a resale purpose is identified, may be classified as commercial imports, requiring customs declaration and payment of duties in the destination country.

4.2 Key Compliance Considerations for Importation into China

When importing health foods into mainland China, the following critical points require attention:

(I) Import as Ordinary Food

If the product holds only ordinary food status (no Blue Cap certification) and is imported as "ordinary food," it must comply with China's National Food Safety Standards:

• Ingredients must appear on China's permitted food ingredient catalogue (certain collagen source animals and extraction methods are already listed, but specific specifications must be verified).
• Labels must include a Chinese-language label; the label content must comply with GB 7718 and GB 28050, and must not contain any health claims.
• The importer must complete registration of the overseas producer in China's customs system (CIFER) or complete the designated importer filing.

(II) Import as Health Food

To sell a product in China as "health food," the manufacturer must submit a registration application to SAMR (imported health foods must obtain an approval number), involving multiple stages including ingredient safety assessment, efficacy trials, and label review. The process typically takes a considerable amount of time. Marketing a product as a health food without having obtained the approval number is a violation of the Measures for the Registration and Filing of Health Foods.

(III) Dedicated Cross-Border E-Commerce Rules

health foods purchased through cross-border e-commerce platforms (e.g., Tmall Global, JD Worldwide) are governed by the Interim Measures for Cross-Border E-Commerce Supervision and are classified as "personal-use inbound goods," exempted from the requirement to obtain a health food registration approval number. However, the platform must complete its qualification filing, and the consumer must sign a personal responsibility acknowledgment. Under this pathway, products do not require a Chinese-language label, but consumers assume the corresponding risks themselves, and these goods are not eligible for the consumer protection mechanisms applicable to health foods.

4.3 Differences Across Taiwan, Hong Kong, and Singapore

• Taiwan: Health foods must obtain certification from the Ministry of Health and Welfare under the Health Food Control Act; uncertified products may only be sold as general food, and labels may not include claims regarding specific health benefits.
• Hong Kong: There is no dedicated pre-market approval system for health foods, but products must comply with the Food and Drugs (Composition and Labelling) Regulations and may not carry medical claims; products containing certain ingredients (e.g., high-dose vitamins or minerals) may trigger pharmaceutical regulation.
• Singapore: Health supplement products are regulated by the Health Sciences Authority (HSA) under the Health Products Act; certain ingredients have maximum permitted levels, and importers must complete product notification.

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V. Actionable Checklist for Consumers

Based on the compliance framework outlined above, consumers selecting collagen health food products may refer to the following checklist:

1. Verify completeness of mandatory label items

Properly labeled products should contain five fundamental elements: manufacturer name and address, best-before date, storage instructions, ingredient names (including additives), and a nutrition facts panel. If label information is incomplete, caution is warranted.

2. Distinguish the product's regulatory category

Check whether the product is labeled as「」(Functionally Labeled Food),「」(Food for Specified Health Uses), or as ordinary food. Notification information for Functionally Labeled Foods can be searched in the CAA's official database, allowing consumers to verify whether the product name and functional claim content are consistent with the database record.

3. Confirm how ingredient quantities are declared

Prefer products that declare the collagen (peptide) content corresponding to the daily intake amount, rather than products that merely state "contains collagen". If molecular weight values and the testing methodology are also disclosed, the level of informational transparency is higher.

4. Verify GMP manufacturing certification

If a product claims to have obtained JHNFA GMP Compliance Certification, the certification number can be used to verify on the JHNFA's official website whether the certification status is valid and whether the certified factory is consistent with the product's manufacturer.

5. Confirm destination market compliance before cross-border purchase

If a product is to be carried to or mailed to mainland China after purchase, confirm that the import quantity falls within a reasonable range for personal use, and familiarize yourself with the destination market's admission rules for that ingredient. Cross-border e-commerce channels and general trade channels are subject to different regulatory rules; consumers must clearly understand which type of purchasing channel they are using.

6. Exercise caution regarding exaggerated claims

Any claim describing specific improvement effects — such as "skin improved after consumption" or "joints repaired" — already exceeds the scope of compliant health food labeling in Japan. When encountering such marketing, verify whether the product genuinely holds the relevant qualifications, or whether the claim originates from the manufacturer's official channels.

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Conclusion

Label compliance for collagen health foods is a composite issue spanning food law, advertising regulation, and cross-border trade. Japan has established a relatively comprehensive tiered regulatory system in this area — from Functionally Labeled Food notification to GMP manufacturing certification — each of which provides publicly verifiable sources of information. For consumers, understanding the logic of this system — which information is a statutory mandate, which constitutes a voluntary standard, and which defines a compliance boundary — offers greater long-term reference value than relying on the endorsement of a single brand.

Cross-border purchasing scenarios add further layers of compliance complexity. Destination markets differ substantively in their conditions for health food admission, labeling requirements, and permitted ingredient lists; "legally sold in Japan" does not equate to "globally compliant." When making a purchasing decision, incorporating the transparency of a product's labeling, the verifiability of its manufacturing certification, and the admission rules of the destination market into a holistic assessment is a pragmatic approach to reducing compliance risk.

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*The information in this document is current as of June 2026. Should the relevant regulations be updated, the official published versions shall prevail. This document does not constitute legal advice, nor does it constitute medical advice of any kind.*