by COVUE

Key Import Regulations You Should Know for Cosmetics & Personal Care Products in Japan

Expanding into the Japanese market presents exciting opportunities for your cosmetics and personal care brand.

The cosmetics and personal care sector in Japan is projected to grow from USD 45.6 billion in 2024 to USD 80.7 billion by 2032, driven by factors such as Japan’s aging population, increasing demand for high-quality and eco-friendly products, and continuous technological innovation. Additionally, the rise of Japanese beauty, along with Korean beauty, and the expansion of eCommerce are contributing to a growing market for both local and international brands.

However, before launching your product in Japan, it’s essential to understand the regulatory landscape. Japan’s import laws ensure product safety and consumer well-being, and conducting a Pre-Market Check is vital to ensure your product meets these standards. In this guide, we will explore the key import regulations for cosmetics and personal care products, focusing on the process, required documentation, and compliance essentials.

Understanding the Regulatory Framework

Japan’s cosmetics and personal care market is heavily regulated by government bodies to maintain high safety standards. The main regulatory bodies are:

Ministry of Health, Labor and Welfare (MHLW): Oversees the regulatory framework for cosmetics under the Pharmaceutical and Medical Devices Act (PMD Act).
Pharmaceutical and Medical Devices Agency (PMDA): Operates under MHLW and is responsible for reviewing import applications, conducting inspections, and processing approvals for new products, including cosmetics and quasi-drugs.

These agencies set the guidelines for product categorization, ingredient safety, and labeling requirements. Understanding their roles is crucial to ensuring your product’s successful entry into the Japanese market.

Key Laws and Regulations Governing Cosmetics and Personal Care Products

Pharmaceutical and Medical Devices Act (PMD Act)

The PMD Act is the principal law regulating cosmetics, quasi-drugs, pharmaceuticals, and medical devices in Japan. The Act ensures the safety, quality, and efficacy of products before and after they are placed in the market. The key points of the PMD Act for cosmetics are:

Product Classification: Differentiates between cosmetics (non-medical use) and quasi-drugs (products with minor therapeutic effects).
Ingredient Standards: Provides a positive list (approved ingredients) and a negative list (prohibited ingredients) for cosmetics and personal care products.
Labeling Requirements: Requires full transparency on product labels, including ingredient listings, usage instructions, and safety information.

Food Sanitation Act

While primarily focused on food safety, the Food Sanitation Act also regulates personal care products that might come into contact with food or packaging materials. This law ensures that all cosmetics and personal care products that come into direct contact with the mouth or food items meet stringent safety standards.

Cosmetics vs. Quasi-Drugs: Classification and Requirements

In Japan, cosmetics and personal care products with minor therapeutic effects can fall into a seperate category, requiring a different import process. Here is an overview of the two categories based on their intended use:

Cosmetics: These products are intended to beautify, maintain, or alter the appearance without affecting the body’s structure or function. Examples include skincare, makeup, and haircare products. Cosmetics are subject to less stringent regulations and do not require pre-market approval, but they must comply with ingredient and labeling standards.
Quasi-Drugs: These products have mild pharmacological effects and can make claims such as treating or preventing minor conditions. Examples include anti-dandruff shampoos, acne treatments, and medicated deodorants. Quasi-drugs are subject to more rigorous regulation and pre-market approval from the MHLW and PMDA.

If you are not sure which category your product will fall into, it is best to consult with an expert. Contact COVUE to review your products today.

The Regulatory Process for Importing Cosmetics and Personal Care Products

Step 1: Pre-Market Check

Before proceeding with importation, it is essential to conduct a Pre-Market Check. This involves:

Verifying Product Category: Determining whether your product is classified as a cosmetic or quasi-drug.
Checking Ingredients: Ensuring that all ingredients comply with Japan’s positive and negative ingredient lists. Any unapproved ingredient may lead to delays or rejection upon import.
Confirming Labeling Compliance: Verifying that your product’s label adheres to Japan’s PMD Act and includes required information (e.g., ingredient list, manufacturer details).
Confirming Lab Testing Requirements: Determining if additional safety and stability testing, such as irritation tests or toxicity assessments, is needed. These tests depend on the ingredients, and lab results are required for import.

At COVUE, we offer an in-house Pre-Market Check to streamline your experience. You will need to provide a document with detailed ingredient lists and their percentages for evaluation. Click here to learn more about why Pre-Market checks are a crucial part of your import process.

Step 2: Cosmetic Import Notification

Once the Pre-Market Check is completed and your product complies with Japan’s standards, you will need to work together with your ACP/IOR who holds a cosmetics license in order to prepare your Cosmetic Import Notification.

Your ACP/IOR will be responsible for submitting a notification to the MHLW, which includes your product’s ingredient list, manufacturing process, and safety documentation. . To prepare the documentation effectively, you will need to share the following items with your ACP/IOR.

Your Ingredient List and the percent of each ingredient
The Manufacturing Flow Process for your product
Product Samples
Images of your product and packaging
Safety documentation or MSDS (if required)
Any lab test reports which are relevant for your product
Any additional documents that may be requested by MHLW

The Pharmaceutical and Medical Devices Agency (PMDA) will review the submission, and approval should take 1-2 months depending on the product’s complexity.

To ensure smooth and timely importation, it’s important to understand the full customs process. Learn more about the essential steps for preparing documentation and ensuring your product’s readiness for import in Japan with our Essential Guide to Navigating Japan’s Customs.

Step 3: Labeling Compliance

For both cosmetics and quasi-drugs, labels must meet Japan’s strict guidelines. Here are the basic requirements:

Ingredient Disclosure: All ingredients must be listed in descending order of concentration.
Language Requirements: The product label must be in Japanese.
Claims: In Japan, claims on cosmetic products are generally not permitted due to strict regulations. It’s important to consult with an expert to make sure you’re following the right guidelines.

Step 4: Customs Clearance

Once your product is approved, you can ship to Japan, and it will need to clear customs. This includes submitting the product documentation (e.g., product notification or approval) to Japanese customs authorities. At this stage, having a local partner like COVUE to handle customs clearance and logistics ensures smooth and timely entry into Japan.

Common Challenges International Brands Might Face

Misclassification: A common issue where a product is mistakenly categorized as a cosmetic instead of a quasi-drug, or vice versa. This can lead to significant delays or extra compliance requirements.
Language Barriers: Japanese regulations are complex and primarily in Japanese. Without a localized team, it’s easy to miss key compliance details.
Documentation Gaps: Incomplete or incorrect ingredient lists or missing safety documentation can result in application rejection.
Shipping Without Import Approval: Shipping products to Japan before obtaining import approval can lead to delays, with the goods being stopped and held in bonded storage. The approval process for cosmetics can take 1-2 months or longer depending on the product, making this a costly mistake if customs holds your shipment.

The consequences of non-compliance include import rejection, costly delays, fines, or even having to pull your product from the market.

Practical Advice for Ensuring Compliance

Conduct a Pre-Market Check: Ensure your product complies with Japan’s strict standards before you begin the import process. It is best to consult with an expert in the Japanese market to ensure this check is done effectively.
Work with Local Experts: Having a trusted local partner like COVUE can help you navigate regulatory challenges, ensuring your product is fully compliant and ready for the market.
Stay Updated: Japanese regulations can change, so keeping up to date with the latest legal requirements is crucial for continued compliance.

Your Path to Smooth Market Entry in Japan

Successfully entering the Japanese market requires thorough preparation and understanding of local regulations, particularly regarding product classification and labeling. By conducting a Pre-Market Check, you can ensure that your product is compliant with Japan’s stringent standards, reducing the risk of costly mistakes and delays. COVUE is here to help you navigate these regulatory requirements and ensure a smooth market entry for your cosmetics and personal care products in Japan.