,
2 min read
Cosmetic products in Japan are regulated by the Ministry of Health, Labour, and Welfare (MHLW) under the Pharmaceutical and Medical Devices (PMD) Act. The MHLW, which is the public Health Authority (HA) in Japan ensures compliance with guidelines for ingredients and labeling.
Cosmetic manufacturers and importers are required to submit a notification before entering the market. To do so, they must first obtain a Marketing Authorization Holder (MAH) license.
The MAH must have a local entity or an appointed local representative, who takes full responsibility for ensuring the compliance of imported cosmetics in Japan.
Why is Marketing Authorization Holder (MAH) required In Japan?
The Key Responsibilities of an MAH are:
- Answers to any remark, request, or communication from HA.
- Acts as the Point of Contact between the HA and the brand owner.
- Assists in collecting and reporting any adverse reaction.
- Informs you about the necessary actions to be taken in case of safety incidents.
- Helps you with the required local language support for communication.
- Ensures ingredients and labeling comply with Japanese standards.
- Provides prompt updates on regulatory labeling/submission changes.
- Guide you through appropriate regulatory pathways, documentation, and interactions with authorities like PMDA.
Key Challenges in Japan’s Cosmetic Registration
- Misleading Claims: Using unapproved claims about product safety or effectiveness can result in fines or outright rejection.
- Quasi-Drug Classification Challenges: Products with functional claims like skin whitening, anti-dandruff, or some of sunscreens are classified as quasi‑drugs. These are subject to more rigorous regulation and pre-market approval is required by the MHLW and PMDA. Misclassification of cosmetics and Quasi-drugs can also delay approvals.
- Ingredient Listing Errors: Missing key ingredients or listing them in the wrong order may cause regulatory delays.
- Labeling Errors: Since all labels must be in Japanese, poor or incomplete translations often lead to compliance problems.
- Marketing Authorization Holder (MAH) Requirement: Foreign companies must appoint a local MAH in Japan to submit notifications and report adverse events to PMDA and manage compliance. Without one, market entry is not possible.
- Prohibited Claims: Claims such as “doctor recommended” or “clinically proven” are banned unless specifically cleared by MHLW.
With increasing demand for cosmetics in Japan, manufacturers must carefully navigate strict regulations, from product classification and labeling to claims review and safety reporting. By adhering to Japan’s stringent requirements, brands can avoid costly setbacks and build consumer trust in one of the world’s most sophisticated markets.
At Freyr, we specialize in guiding companies through every step of the Japan’s cosmetic registration process — from MAH support to regulatory submissions and compliance monitoring. If you’re looking to launch your cosmetics in Japan, our experts are here to ensure your products meet the highest standards of quality and safety.
Contact Freyr today!
