Thailand Reach Regulation for Various Sectors

The cosmetic control in Thailand has been implemented by the Cosmetic Act B.E. 2558 (2015) which is under the regulation of Thailand FDA. The ASEAN Cosmetic Directive originated under the agreement of the ASEAN Harmonized Regulatory Scheme and the regulation of Thailand FDA. 

• The Minister of Public Health is in charge of formulating and issuing cosmetic regulations, measures and standards and the execution of the regulations. 

• The Food and Drug Administration regulates the notification and post-market surveillance of cosmetic products. 

• Any company or a single individual who wants to import or manufacture cosmetics product for sale in the kingdom, must inform about the complete details of cosmetic product to be imported or manufactured to the authority of concern.  

• The submission and issuance of Import permit or information receipt should strictly follow the regulation and condition as specified by ministerial regulation of Ministry of Public Health.  

• The import permit or manufacturing permit or information receipt is issued by Cosmetic division of Thai FDA. Once issued the permit, it is valid for the time period of 3 years from the date of issue.  

• Renewal of such permit should be applied before the expiry of the information receipt.  

• Thai FDA implies following regulatory measure to ensure quality and safety of cosmetic product manufactured or imported in Thailand 

• 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. Information must be written in Thai language and must be the size that is easily legible. The content written over the label must be accurate and must not be misleading to anyone. References (from where content included) must be documented for inspection. 

• The cosmetic product must be advertise based on its fact without misleading the content/ reference. References should be documented for inspection. 

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. 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 

• Labelling 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 

All cosmetic products must have Thai legal labelling within 30 days after importation date before putting in market. Labels must bear the following information: 

• Product name and trade name: (Font size must be bigger than other content) 

• Type: (i.e. shampoo, conditioner, whitening skin care, etc) 

• Full ingredient list (FIL) 

• Direction for use 

• Manufacturer name + country or Importer name + address 

• Net content in metric (ml or gram): (Font size 2mm. (<50)3mm (50-200)4 mm. (200-1000) 5mm (1000 up) 

• Batch no 

• Manufacturing date 

• Expiry date (for products with shelf-life less than 30 months) 

• Warning (in accordance with MOPH notification) 

• Notification receipt number 

Any products having pharmaceutical characteristics such as those affecting or altering the functions or structure of human body or presenting as pharmaceutical products are outside the scope of cosmetic regulation. List of names of cosmetic products prohibited for manufacturing, importing and sale defines certain cosmetics which are prohibited for manufacture, import and sale. Some prohibited and restricted substances are preservatives, colorants and sunscreens.