Japan Cosmetics and Quasi-drug Notification Guidance

1. Background Introduction

The Pharmaceuticals and Medical Devices Act (PMD Act, formerly known as the Pharmaceutical Affairs Law) is the core legislation governing the research, development, manufacturing, importation, and distribution of cosmetics, pharmaceuticals, and quasi-drugs in Japan. Since its initial enactment, the Act has undergone multiple revisions to enhance the assurance of product safety, efficacy, and quality, while safeguarding public health and consumer rights.

Under the PMD Act, products are primarily classified into cosmetics and quasi-drugs. To strengthen regulatory oversight, protect public health, and improve transparency of pre-market information, the Ministry of Health, Labour and Welfare (MHLW) and its subordinate agencies have established a comprehensive system for product classification, notification, approval, and post-market surveillance.

This guidance is developed based on the current Japanese legal and regulatory framework. It systematically outlines the definitions of cosmetics and quasi-drugs, requirements for product notification, obligations of responsible entities, and compliance procedures. The aim is to assist enterprises in thoroughly understanding the regulatory landscape for market access in Japan, standardizing product notification practices, minimizing compliance risks, and ensuring lawful and efficient market entry.

2. Definition of Cosmetics and Quasi-drug

2.1 Cosmetics

According to the Pharmaceuticals and Medical Devices Act (PMD Act) of Japan, cosmetics are defined as “articles with mild action on the human body, which are intended to be applied to the human body by rubbing, sprinkling or other similar means, for the purpose of cleansing, beautifying, enhancing attractiveness, altering the appearance, or keeping the skin or hair in good condition. However, this does not include articles that are intended for uses other than the above purposes and that also fall under the uses specified in Item 1 of Paragraph 2 or Item 2 of Paragraph 3 of the definition of pharmaceuticals.”

Note 1: Articles intended for use in the diagnosis, treatment, or prevention of diseases in humans or animals.

Note 2: Articles intended to affect the structure or functions of the body of humans or animals.

2.2 Quasi-drug

According to the Pharmaceuticals and Medical Devices Act (PMD Act) of Japan, quasi-drugs are defined as “products that exert a mild effect on the human body and are intended for the following purposes. This includes:

Products intended for the purposes listed in items①to③below, excluding apparatus and devices. However, this does not include products that are intended for purposes other than those listed below and that also fall under the uses specified in Item 1 of Paragraph 2 or Item 2 of Paragraph 3 of the definition of pharmaceuticals.

① Prevention of nausea, other discomfort, halitosis, or body odor;

② Prevention of heat rash, chafing, etc.;

③ Prevention of hair loss, promotion of hair growth, or hair removal.

Products intended for the prevention or control of mice, flies, mosquitoes, or other similar organisms, used for the purpose of protecting human or animal health, excluding apparatus and devices. However, this does not include products that also fall under the uses specified in Item 1 of Paragraph 2 or Item 2 of Paragraph 3 of the definition of pharmaceuticals.”

Note 1: Articles intended for use in the diagnosis, treatment, or prevention of diseases in humans or animals.

Note 2: Articles intended to affect the structure or functions of the body of humans or animals.

3. Regulatory Authorities for Cosmetics in Japan

In Japan, the Ministry of Health, Labour and Welfare (MHLW), specifically its Pharmaceutical and Food Safety Bureau, is the primary authority responsible for the regulation of cosmetics and quasi-drugs. Its main duties include the formulation of relevant laws and regulations, approval and licensing management, ingredient safety evaluation, supervision of labeling and advertising, as well as coordination with local regulatory bodies. Post-marketing surveillance and regulatory oversight of cosmetics and quasi-drugs are primarily carried out by the local authorities of each prefecture.

At the same time, within Japan’s regulatory framework for cosmetics and quasi-drugs, a technical support system has been established to provide strong backing for regulatory implementation and product safety. The technical support system mainly includes:

Pharmaceuticals and Medical Devices Agency (PMDA)

On April 1, 2004, the Pharmaceuticals and Medical Devices Evaluation Center of the National Institute of Health Sciences, the Organization for Pharmaceutical Safety and Research (OPSR), and certain departments of the Medical Devices Center were integrated to officially establish the Pharmaceuticals and Medical Devices Agency (PMDA).

Main responsibilities include:

• Conducting evaluations of pharmaceuticals and medical devices in accordance with relevant regulations, including marketing authorization reviews;
• Implementing health hazard relief services for adverse drug reactions;
• Ensuring the quality of pharmaceuticals and medical devices by publishing safety measures and related information.

Japan Cosmetic Industry Association (JCIA)

Established in 1950, the JCIA has 13 specialized committees, including those focused on alternatives to animal testing, raw material standards, colorants, microbiology, ultraviolet rays, and other areas crucial to cosmetics. It publishes the “Guidelines for Safety Evaluation of Cosmetics.”

Japanese Society of Cosmetic Chemists (JCSS)

Initially founded by dermatologists and researchers in cosmetics and pharmaceuticals, it serves as a platform to discuss medical and scientific issues related to cosmetics and related substances. It is a venue for presenting research findings on the safety and efficacy of cosmetics. The JCSS has developed guidelines such as the “Evaluation Guidelines for Anti-Wrinkle Products with New Efficacy Claims (Quasi-drug Approval)” and the “Evaluation Guidelines for Whitening Efficacy with New Efficacy Claims (Quasi-drug Approval).”

4. Marketing Authorization Holder (MAH)

According to the regulations of the Ministry of Health, Labour and Welfare (MHLW) of Japan, foreign cosmetic companies intending to sell cosmetic products in Japan must designate a corporation within Japan that holds a “Cosmetics Marketing Authorization License” (化粧品製造販売業許可) as the Marketing Authorization Holder (MAH). The MAH is responsible for product notification, regulatory compliance, and post-marketing quality and safety oversight.

Note: If the cosmetic products involve actual operations such as manufacturing, processing, packaging, labeling, or storage, the relevant facilities must also obtain a “Cosmetics Manufacturing License “(化粧品製造業許可).

5. Requirements for Placing Cosmetics on the Japan Market

The following content will systematically outline the key regulatory requirements and compliance procedures for marketing products in Japan, categorized into two main groups: cosmetics and quasi-drugs. This section focuses on the requirements for marketing cosmetics in the Japanese market, while the next section will address the requirements for quasi-drugs.

5.1 Compliance Procedure

The diagram below illustrates the compliance procedure for marketing cosmetics in Japan.

The Marketing Authorization Holder (MAH) is required to obtain a Marketing and Sales License and is responsible for the post-marketing safety of the product.

5.2 Documentation Requirements  

In Japan, cosmetic products must undergo a notification process before they can be marketed. Relevant documentation must be submitted through the Ministry of Health, Labour and Welfare’s online application system, FD Application (https://web.fd-shinsei.mhlw.go.jp/).

Specifically, companies are required to submit the “Cosmetic Marketing Notification Form (化粧品製造販売届書)”, which includes basic information such as the product name, key ingredient details, a brief description of the manufacturing process, the manufacturing site, and its address. For imported cosmetics, an import notification is also required. This includes submitting information about the overseas manufacturer, such as the company name, address, and country or region of origin, to ensure traceability and regulatory compliance of the product source.

5.3 Ingredient Requirements

In Japan, the use of cosmetic ingredients is regulated by relevant laws and standards. The Standards for Cosmetics (化粧品基準) specify 30 prohibited ingredients and 17 restricted ingredients, as well as 48 approved preservatives and 31 approved UV filters. Apart from these specifications, companies may use other ingredients at their own risk, provided they ensure product safety.

In addition, the Ministerial Ordinance on Tar Colors Permitted for Use in Drugs, Quasi-drugs, and Cosmetics stipulates the use of 83 coal tar colors, categorized into three parts: Part I: 11 colors, Part II: 47 colors and Part III: 25 colors. For cosmetics that come into contact with mucous membranes, only colors listed in Part I and Part II may be used. However, hair products intended for washing or dyeing purposes may, in principle, use all three categories of coal tar colors.

Hair dyes are classified as quasi-drugs in Japan, and their raw materials are regulated under the Standards for Approval of Hair Dye Marketing Authorization (染毛剤製造販売承認基準), which currently lists 75 permitted hair dye ingredients.

5.4 Manufacturing Requirements

Japanese domestic manufacturers are required to obtain a manufacturing license. Compliance with the Good Vigilance Practice (GVP) and Good Quality Practice (GQP) for pharmaceuticals, quasi-drugs, cosmetics, and medical devices is a necessary condition.

5.5 Product Safety

In Japan, cosmetic companies bear primary responsibility for the safety and quality of their products. Final products must comply with the relevant requirements of the cosmetic standards, and the sale of deteriorated products, products contaminated with foreign substances, or products affected by microbial contamination is strictly prohibited. Companies are required to conduct sufficient safety assessments before products are placed on the market and to properly retain relevant records. Specific management points and key testing requirements include:

• Safety Assessment Report: Follows the principle of company-led self-management. The JCIA has issued the Guidelines for Cosmetic Safety Assessment, advocating for product-based assessments.
• Toxicological Testing: The Cosmetic Safety Evaluation Guidelines (2008) issued by JCIA include some OECD-accepted alternative test methods for reference. Some major Japanese cosmetic companies have publicly declared that animal testing is no longer used in the development of cosmetic products in Japan.
• Heavy Metals: Mercury and its compounds, cadmium compounds, strontium compounds, and selenium compounds are prohibited ingredients. According to the Quality Assurance of Cosmetics, the limit for arsenic is less than 10 ppm.
• Microorganisms: The Ministry of Health, Labour and Welfare has not issued specific regulatory documents regarding microorganisms in cosmetics. However, according to JCIA internal technical materials, the industry generally refers to the following microbial control standards to ensure product hygiene and safety.

5.6 Labeling Requirements

According to the Pharmaceutical and Medical Device Act (PMD Act) of Japan, the following information must be labeled on cosmetic product packaging:

• Name and address of the manufacturer or distributor
• Product name
• Batch number or manufacturing code
• Full ingredient list
• Expiration date (labeling is not required if the product is stable for more than 3 years)
• Precautions for use (when necessary)
• Other necessary information (e.g., country of origin, container/package recycling method, etc.)

5.7 Claims and Advertising Requirements

The Ministry of Health, Labour and Welfare (MHLW) in Japan has issued the Revision of the Scope of Cosmetic Efficacy Claims, and the Japan Cosmetic Industry Association (JCIA) provides the Guidelines for Appropriate Advertising of Cosmetics, etc. These documents serve as important references for cosmetic product claims in Japan. A total of 56 types of efficacy claims are permitted for cosmetics under these guidelines.

• Note : For claims with conditions indicated in parentheses, the function must be achieved under the specified conditions; otherwise, it may be considered misleading regarding quasi-drug functions.
• Expressions outside the 56 officially recognized cosmetic claims are permitted as long as they are not false, such as “prevents makeup from coming off,” “makes the skin look refreshed,” “gives a cooling sensation,” or “feels fresh.”

6. Requirements for Placing Quasi-drug on the Japan Market

6.1 Compliance Procedure

The diagram below illustrates the compliance procedure for marketing quasi-drugs in Japan.

• Other Quasi-drugs

• Hair Dyes, Hair Perming Agents, Medicated Toothpaste and Medicated Bath Additives

6.2 Documentation Requirements

The application for marketing authorization of quasi-drugs must be submitted via the FD Application System (https://web.fd-shinsei.mhlw.go.jp/). Required documents include: an overview sheet, application form for approval, instructions for precautions during use, relevant supporting documents (such as manufacturing license certificates, joint development agreements, etc.), various test reports (covering safety, stability, efficacy, etc.), as well as other supplementary materials for reference.

6.3 Ingredients Requirements

In Japan, the use of ingredients in quasi-drugs is likewise regulated by relevant legislation.

Japan has established a comprehensive set of detailed regulations governing the use of ingredients and product approval for quasi-drugs, covering various technical requirements and ingredient management aspects. For example, the Standards for Quasi-drug Ingredients specify clear criteria for the quality, purity, stability, and safety of ingredients; the List of Additives for Quasi-drugs includes 2,746 approved additive ingredients permitted for use in quasi-drugs; the List of Active Ingredients for Medicated Cosmetics outlines the names and usage requirements of active ingredients corresponding to eight categories of medicated cosmetics; and the List of Permitted Ingredients for Hair Waving Products covers 1,836 ingredients allowed in hair waving products along with their maximum concentration limits.

In addition, the Marketing Authorization Standards for Medicated Toothpaste Products specify the active ingredients and usage conditions corresponding to different efficacy claims; the Ministerial Ordinance on Coal Tar Colors Permitted for Use in Pharmaceuticals, etc. addresses 83 coal tar-based colorants, which are, in principle, allowed for use in hair products intended for cleansing or dyeing purposes; the Marketing Authorization Standards for Hair Dyes list 75 hair dye ingredients; and the Marketing Authorization Standards for Bath Additives identify 25 active ingredients recognized for their therapeutic bathing effects.

6.4 Manufacturing Requirements

In Japan, domestic companies intending to engage in the manufacturing of relevant products must obtain a manufacturing license and comply with the Good Vigilance Practice (GVP) and Good Quality Practice (GQP) standards for pharmaceuticals, quasi-drugs, cosmetics, and medical devices. For imported products, corresponding manufacturing documentation must also be submitted, and, when necessary, a GMP conformity inspection may be conducted to ensure that the production quality and safety management systems meet Japanese regulatory standards.

6.5 Product Safety

In Japan, quasi-drugs are subject to a licensing system. According to the Guidelines for Licensing Applications of Quasi-drugs, applicants are required to submit varying levels of physicochemical analysis, stability, and toxicological test reports depending on whether the product contains new active ingredients or new additives (non-active ingredients), or involves a new dosage form, new concentration, new combination, or new usage method.

• The content, properties, and quality of the ingredients must be consistent with those already approved.

6.6 Labeling Requirements

According to Japan’s Pharmaceuticals and Medical Devices Act (PMD Act), quasi-drug packaging must display the following information:

• Name and address of the marketing authorization holder;
• The term “Quasi-drug”(医薬部外品);
• Product name;
• Manufacturing batch number or identification code;
• Quantity, volume, or unit count;
• Active ingredients;
• Other ingredients;
• Expiration date (not required if the shelf life exceeds three years);
• Precautions for use (if necessary);
• Other required information (e.g., country of origin, container/package recycling instructions).

6.7 Claims and Advertising Requirements

In accordance with the Standards for Appropriate Advertising of Pharmaceuticals, etc. and the Guidelines and Precautions for the Standards for Appropriate Advertising of Pharmaceuticals, etc. issued by the Ministry of Health, Labour and Welfare (MHLW), the following are the classifications and scope of permitted claims for quasi-drugs:

In addition to the aforementioned categories, newly designated quasi-drugs also include throat-refreshing agents, stomach-refreshing agents, topical disinfectants, wound disinfectants, preparations for chapped skin, and treatments for heat rash and associated skin erosion.

The efficacy of quasi-drugs must be achieved through the addition of functional active ingredients. Therefore, when applying for regulatory approval of a quasi-drug, it is necessary to submit safety information related to the active ingredients, as well as efficacy verification reports for the product.

7. Notification Timeline

The time required for key stages may vary depending on factors such as the product category, the formulation complexity and the necessary testing. Below is a reference table outlining the estimated timelines for Japan cosmetic and quasi-drugs notification. For further professional assistance, please contact CIRS Group (cosmetic@cirs-group.com).

8. Post-Market Supervision Requirements

To ensure product safety and protect consumer health, Japan implements post-market surveillance and adverse reaction response mechanisms for cosmetics and quasi-drugs.

Under the Pharmaceuticals and Medical Devices Act (PMD Act), manufacturers, importers, and distributors are responsible for ensuring the safety and compliance of products during distribution and use. Regulatory authorities-such as the Ministry of Health, Labour and Welfare (MHLW) and local pharmaceutical regulatory offices-conduct oversight through regular or ad hoc on-site inspections, product sampling and testing, and label reviews. Companies are required to maintain records related to manufacturing, quality testing, sales, and customer complaints to ensure traceability and facilitate regulatory supervision.

If a company becomes aware of adverse reactions such as rashes, swelling, or allergic responses associated with product use, it is obligated to report these incidents to the MHLW or relevant local authorities in accordance with the PMD Act and related administrative notifications. The report must include product details, a description of the event, corrective actions taken, and measures to prevent recurrence. Companies must establish a robust customer complaint handling mechanism and an adverse event reporting system to ensure timely receipt and follow-up of consumer feedback. In the case of serious adverse events, companies are required to take prompt actions, such as voluntary recalls of affected batches, issuing consumer alerts, or revising product labeling and instructions. Regulatory authorities may conduct risk assessments based on the reports submitted, and may initiate market investigations or issue administrative guidance to mitigate risks and ensure the safe use of products by consumers.

Our Services

• JP Cosmetics and Quasi-drug Notification
• Dossier Preparation
• Formula and Label Review
• Testing Required for the Notification

If you need any assistance or have any questions, please get in touch with us via cosmetic@cirs-group.com.