Thailand Cosmetic Regulation Overview
The cosmetic control in Thailand has been implemented by the Cosmetic Act B.E. 2558 (2015) which is regulated by the Thailand FDA under the agreement of the ASEAN Harmonized Regulatory Scheme and the regulation called the ASEAN Cosmetic Directive.
According to the Cosmetic Act B.E. 2558, cosmetics are classified as general cosmetics, controlled cosmetics, and specially controlled cosmetics. Three categories of cosmetics will face different legal requirements. Following is their definitions and requirements:
|Cosmetic Classification||Description||Legal Requirements|
|General Cosmetics||The products which do not fall under specially controlled or controlled cosmetics.||Notification|
|Controlled Cosmetics||The products containing ingredients that may cause harmful effects if the used concentrations exceed the maximum allowable levels.||Notification|
|Specially controlled cosmetics||The products may cause serious harm to users or that contain toxic substances or other substances which cause serious harm to the health of users.||Registration|
Technical Requirements of Cosmetics
The technical requirements cover the positive and negative listings of ingredients, labeling and claims, pre-marketing requirements, and Good Manufacturing Practices (GMP). These technical requirements serve as the guidelines for quality and safety control.
Manufacturers or importers of cosmetic products must notify the information of cosmetic products to the authority prior to producing or importing at the customs. The steps for notification are as follows.
- Notify the information of cosmetic products to the authority prior to producing or importing. Once the information is completed and correct, the applicant will receive the notification receipt which is valid for 3 years.
- Manufacture or import the cosmetic product according to the notification.
- Prepare label: The information must be written in the Thai language and must be the size that is easily legible. The contents must be accurate and must not be misleading. References should be documented for inspection.
- Advertise cosmetic products based on its fact without misleading content. References should be documented for inspection.
Steps of Cosmetics Notification on General and Controlled Cosmetics
- Applicants are manufacturers (repackaging included), original equipment manufacturers, and importer.
- Information for notification includes
2.1 Information of the applicant such as name and address of manufacturer or importer or storage site
2.2 Information on cosmetic products such as name, Brand name ( Trade name), categories and ingredients.
2.3 Submitting a notifying form (Jor Kor)
If the manufacturing or storage sites are located in Bangkok, the manufacturers or the importers must notify at the Food and Drug Administration office. If the manufacturing or storage sites are located in other provinces, the manufacturers or the importers must notify at the provincial public health office where the sites are located. The manufacturers or the importers may also notify the information via the computer network of the Food and Drug Administration.
Cosmetics Labeling Requirements
The labeling requirements endorsed by the Cosmetic Committee stipulate that all cosmetics must be labeled in the Thai language covering all aspects of information in compliance with the requirements.
|Labeling Requirements of Cosmetics|
|1. Product name and Brands’ name|
|2. Type of product, Catagories|
|3. All ingredients|
|4. Instructions for use|
|5. Name and address of the manufacturer (Name and address of importer including the name of manufacturer and country of origin)|
|6. Net contents|
|7. Batch number|
|8. Manufacturing date|
|9. Expiry date|
|10. Statutory warning|
|11. Notification number|
Note: the words “Specially Controlled Cosmetics” & Registration number or “Controlled Cosmetics” shall be listed for the specific categories.
The labels of cosmetic products may present the claims of use within the scope of cosmetics similar to those claims presented in advertising. The manufacturers or importers must retain the profile of product information including the evidence supporting those claims. Claims must not indicate that the products have any pharmaceutical characteristics or capability to affect or alter the human body’s functions or structure. Additionally, these claims must not indicate that those cosmetic products have the capability which, in fact, does not exist (overclaim) or is the cause of misunderstanding in their quality (misleading).
Registration of Specially controlled cosmetics
Permission for manufacturing or importing samples of products for registration is required before the registration process begins. The manufacturer or importer shall submit an application with attachments to FDA for review.
After received the permission for manufacturing or importing the sample, a reasonable quantity of samples could be manufactured or imported; and then such samples shall be submitted as an attachment of the registration application. Basically, the registration of specially controlled is normally concluded within 30 working days.
The Requirements for Registration of Specially Controlled Cosmetics
- Application form and attachment
- Master formula certified by the authorized person
- Certificate of free sale (for the importation of products) duly notarized by the Thai Embassy
- Corporation registration issued by the Ministry of Commerce of Thailand
- Labeling information
- Analysis method approved by the Medical Sciences Department of the Thai Ministry of Public Health
- Storage direction
- Photocopy of sample permit
- Batch process
- Sample products
- Photocopy of draft label
- Documents indicating evidence for supporting claims