Japan Revises Rules on Special Labeling of Specific Ingredients in Cosmetics

On March 10, 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) issued a notification announcing revisions to the Special Labeling of Specific Ingredients in Cosmetics regulations. This update repeals and replaces the previous rules that had been in effect since 1985, introducing a more stringent regulatory framework governing how specific cosmetic ingredients may be featured in advertising and product labeling.

What is Special Labeling of Specific Ingredients?

In Japan, “Special Labeling” refers to the practice of displaying certain ingredients in a prominent manner in cosmetic advertising and packaging. While such labeling is, in principle, prohibited due to the risk of misleading consumers into believing the product contains pharmaceutical ingredients or offers drug-like effects, it is permitted under the following conditions:

• The claimed purpose of the ingredient falls within the 56 permitted cosmetic efficacy claims.

• The purpose of the ingredient is clearly stated.

• The information is presented in a way that prevents consumer misunderstanding (e.g., it must not suggest pharmaceutical or therapeutic effects).

                               (An example of compliant labeling)

Key Regulatory Updates

1. Requirements for Objective Evidence of Ingredient Claims

Under the revised framework, any mention of a specific ingredient’s function—such as “moisturizing,” “brightening,” or “soothing”—must now be based on the product’s efficacy and formulation technology, and must be objectively substantiated. Acceptable evidence may include internal or external data, provided it is objective and scientifically sound. It is therefore essential to confirm the validity of such claims with the product manufacturer when producing advertising materials.

2. Mandatory Disclosure of Ingredient Purpose in Visual Representations

Visual representations—including images, design elements, and foreign-language text—that feature specific ingredients are now subject to the same regulatory standards as written claims. When an ingredient is highlighted visually, its name and its intended function must be explicitly displayed. This aims to ensure that visual emphasis does not lead to misleading or unsupported impressions of the ingredient’s efficacy.

3. Expanded Scope of Labeling Oversight

The scope of labeling control has been expanded to include general or category-based terms such as “plant extract” or “marine essence,” which were not previously subject to strict regulation. When such terminology is used, the specific ingredient and its purpose must be disclosed to avoid vague or ambiguous expressions. However, product-defining terms like “amino acid shampoo” are exempt from these requirements, as they indicate the product type rather than the function of a specific ingredient.

4. Dual-Regulation for Quasi-Drug Ingredients

The revised rules also introduce a dual-regulatory approach for ingredients used in quasi-drugs:

• For non-active ingredients, special labeling is permitted only if it aligns with the criteria applicable to cosmetics—namely, the purpose must be objectively verifiable and not misleading, with no implication of pharmacological effects.

• For active ingredients approved in quasi-drugs, stricter conditions apply. Claims suggesting drug-like efficacy—such as “anti-inflammatory”—are prohibited unless specifically approved. However, claims consistent with cosmetic efficacy, such as “skin protection,” may be permitted if:

  - They do not suggest medical or drug-like effects;

  - The purpose is clearly stated alongside the ingredient name;

  - The claim is supported by appropriate evidence and evaluated within the context of the overall advertisement.

Conclusion

The updated guidance from MHLW marks a shift toward evidence-based and transparent advertising and labeling standards for cosmetics. Moving forward, stakeholders shall work closely with manufacturers to verify the accuracy and substantiation of claims related to specific ingredients. All parties are advised to review the revised requirements carefully and adjust their advertising and labeling practices accordingly to ensure compliance.

Further Reading

• Cosmetics Advertising Regulations in Japan

• Japan Cosmetic Regulation