FDA Registration for Homemade Cosmetics in Thailand
Question
How can I obtain FDA registration (เลขจดแจ้ง อย.) for cosmetics I manufacture at home in Thailand? What are the official requirements for manufacturing facilities, and is it possible to register products made in a home setting? Are there alternative methods, such as registering through an established cosmetic factory, and what are the considerations for such methods?
Answer
Subject: FDA Registration for Homemade Cosmetics in Thailand
Regarding your question about obtaining FDA (อย.) registration for cosmetics produced at home in Thailand:
Officially, under Thai law, cosmetics must be notified (จดแจ้งเครื่องสำอาง) with the FDA before being manufactured for sale or imported. The notification is done by the manufacturer (for domestically produced cosmetics) or the importer.
Here's a general overview of the official process:
- Manufacturer/Importer Registration: The entity responsible for manufacturing or importing must be registered with the FDA.
- Product Notification: For each cosmetic product, details must be submitted to the FDA, including:
- Product name
- Category
- Formula (listing all ingredients with their percentages or concentration ranges)
- Manufacturing process
- Labeling information
- Information about the manufacturer (including details about the manufacturing facility)
- Facility Requirements: This is where homemade production faces challenges. Official regulations require manufacturing facilities to meet specific standards regarding hygiene, quality control, and proper manufacturing practices (GMP). A typical home kitchen or workspace may not meet these requirements.
- Obtaining the Notification Number: Once the FDA reviews and accepts the notification, a unique notification number (เลขจดแจ้ง) is issued for the product. This number must appear on the product label.
Can homemade cosmetics get registered?
Directly registering cosmetics produced in a non-standard, non-GMP compliant home environment is generally not possible under the official regulations because the manufacturing facility itself needs to be registered and meet specific standards.
The situation you described, where customers are asking for a registration number, is common because having this number is a legal requirement for selling cosmetics in Thailand and assures customers that the product has gone through the official notification process.
The workaround mentioned in the reply you included, involving registering through an established cosmetic factory, is a method sometimes used to obtain a registration number. In this scenario, the factory acts as the official manufacturer on record, using their registered facility and potentially a formula provided by you (or a variation of it) for the notification process. You would then typically purchase the product (or a base) from them. While this might provide a registration number, it's important to ensure that the product you ultimately sell aligns with the formula and manufacturing process that was officially notified, and that your own handling and packaging processes maintain hygiene and quality standards. Selling a product under a registration number obtained for a different formula or manufacturing process could potentially lead to legal issues if problems arise.
In summary, while you cannot officially register a product manufactured in a typical home setting, obtaining a registration number is crucial for legal sale and customer trust. The official route requires manufacturing in a compliant facility. Working with a registered factory is a common practical approach to navigate this, but requires careful consideration to ensure compliance and product quality.