The beauty and skincare market in Thailand continues to grow rapidly. International brands, local startups, and online sellers are all expanding into this sector because Thai consumers are highly engaged in skincare, makeup, and wellness products. However, before any cosmetic product can legally enter the Thai market, the first and most essential step is completing the FDA Cosmetic Notification process/FDA registration in Thailand.
If this is your first time dealing with Thai regulations, the process can feel confusing. This guide is everything you need to know. It offers a clear understanding of requirements, documents, timelines, and how to make the registration smooth and compliant without delays.
What Is Considered a Cosmetic in Thailand
Thailand defines a cosmetic as any product used on the human body for cleaning, beautifying, modifying appearance, or maintaining good condition. This includes:
- Skincare such as creams, serums, toners, masks
- Makeup such as foundation, lipstick, eyeshadow
- Fragrance and body spray
- Shampoo, conditioner, body wash
- Sunscreen and sun protection products
- Nail polish and nail care
- Lip balm or lip treatment
As long as the product is not treated as a medicine and is used externally for appearance or hygiene, it is classified as a cosmetic.
Even though cosmetics seem simple, they still require an official notification under Thai FDA before selling or importing.
Do Cosmetics Need FDA Approval in Thailand
Yes. All cosmetics must be registered under the Thai FDA system. However, cosmetic products do not require full approval. They follow a notification process. This means the FDA checks the product information but does not issue a long-form license like medical devices or supplements.
Even though it is called a notification, the FDA still carefully verifies:
- Ingredient list
- Concentration levels
- Accuracy of labelling
- Safety of the product
- Valid manufacturing GMP
- Importer information
If anything is non-compliant, the notification will be rejected, and the product cannot be sold.
Types of Cosmetics Under Thai FDA
Thailand divides cosmetics into two groups. Understanding your product classification helps you prepare the correct documents.
Controlled Cosmetics: Controlled cosmetics contain specific ingredients that require detailed documentation. Examples include:
- Sunscreen with UV filters
- Whitening or brightening products
- Acne products containing certain actives
- Products using strong acids or exfoliators
- Products with regulated colorants
These may require MSDS or supporting tests depending on the formulation.
General Cosmetics: General cosmetics include products with standard, low-risk ingredients such as:
- Moisturizers
- Perfumes
- Shampoo and body wash
- Basic makeup
- Lip balm
- Cleansing oil
These usually move through the FDA process much more quickly.
Documents Required for Cosmetic FDA Registration
Preparing the correct documents is essential for a smooth process. Missing information leads to delays or rejection.
1. Full Formula : The ingredient list must add up to exactly 100 percent. This is one of the strictest requirements. Each ingredient must have:
- INCI name
- Percentage
- Role or function (optional but recommended)
Any formula that does not equal 100 percent will be rejected immediately.
2. Product Information File: Thailand requires a complete Product Information File or PIF. This includes:
- Manufacturing method
- Safety documents for specific actives
- MSDS for risky ingredients
- Stability test if available
- Country of origin documents
3. Storage / Office Details
For imported products, the FDA requires:
- Physical office is required
- Warehouse separate is required
- Certificate of Free Sale in some cases
- Clear product photographs
4. Thai Label
All cosmetic products sold in Thailand must include a Thai label. This must include:
- Product name
- Intended use
- Full ingredients
- Instructions
- Manufacturer and importer details
- Batch number
- Net content
- Warnings if required
The Thai label must be accurate and legally compliant before submission.
5. Authorized Agent in Thailand
Foreign brands without a Thai company must appoint a Thai agent. The agent is responsible for submitting documents, managing the FDA portal, and holding the Notification Certificate. Act and Align Advisor provides this service to ensure full legal compliance.
