Wiselink Group
Hazardous Substances Registration in Thailand
Thai FDA registration for Hazardous Substances and Warehouse Registration
Register Hazardous Substances in Thailand for Import: We Manage This Complex Process for You
Wiselink Group has an internal Regulatory Department that provides Hazardous Substances Registration with Thai FDA, handles your license requirements, and manages your stock from import to delivery.
Hazardous Substances are strictly regulated by the Hazardous Substances Act 1995 and its 7 successive amendments.
They are divided into 4 categories based on risk profile. The registration process, timeline, and associated costs vary according to the classification category.
We assist throughout the entire Hazardous Substances Registration process, offering additional secure services including License Holding and warehousing solutions for a monthly fee.
WISELINK GROUP SERVICES
Register Hazardous Substances in Thailand for import? We do it, with or without your registered local unit!
Type 1 and 2 Substances
In such classes fall substances that have less impact on human health and environment than other types. Type 1 requires only notification and labelling, without registration. Examples of Type 1 hazardous substances include cleaning products, such as dish washing products and laundry detergents.
Type 2 products must obtain registration. Examples include household health pesticides and disinfectants.
Type 3 Substances
The Type 3 hazardous substance requires product registration certificate from Thai FDA. Manufacturers, importers, exporters or professional users of Type 3 hazardous substances must receive permission from the authority before using such products. Examples include pesticides containing pyrethroids as active ingredients and cleaning products or disinfectants containing acids, alkalines, or aldehydes.
Type 4 Substances
The Type 4 hazardous substance represents materials with high risks from either their applications or intrinsic properties, e.g., carcinogens, mutagens, reproductive toxicants or substances prohibited by related conventions. Manufacturing, import, export or possession of such substances is prohibited. Examples of Type 4 hazardous substances include DDT, Chlordane, and Dieldrin.
OUR STANDARD PROPOSAL FOR REGISTRATION OF HAZARDOUS SUBSTANCES
Wiselink Group registers your Hazardous Products in Thailand under your license or its own license. Your company will be designated as the Importer (with submission of appropriate GMP certification from manufacturer) and will use its venue to be recorded as the registered business place with Thai FDA.
After warehouse accreditation is completed, Hazardous products will be registered, and required labels will be created and applied to the packaging.
Upon completion of import procedures, products will be either stored and delivered to end users (for Type 1 and 2 Hazardous Substances) or transferred to authorized distributors/users (for Type 3 or 4 substances).
Time required for Hazardous Products registration ranges from 4 to 8 months. If you do not have a local unit, Wiselink Group can establish and register your company in Thailand and obtain all necessary licenses.
GENERAL GUIDELINES FOR HAZARDOUS SUBSTANCES REGISTRATION IN THAILAND
The classification of hazardous substances is determined by the product's ingredients. Each ingredient must be verified against the FDA database system for type determination. When a product contains multiple ingredients of different hazard types, the product classification will be based on its most hazardous ingredient.
For Thai FDA, products are classified as hazardous substances based on their intended purpose.
The Hazardous Substance Act B.E. 2535 (1992) classifies hazardous substances into 4 types. The comprehensive list of hazardous substances, their classifications, responsible agencies, and control conditions are detailed in the annexed table of the Ministry of Industry's Notification on List of Hazardous Substances.
Steps for checking your Hazardous Products
To determine if a chemical or product is a hazardous substance under Thai FDA jurisdiction, follow these verification steps:
1. Verify if the product's active ingredients match any chemicals listed in "List 4.1" and confirm their use aligns with specified conditions.
2. Check if the product's active ingredients belong to any chemical groups in "List 4.2" and verify their use complies with stated conditions.
3. Confirm whether the product's use or claims correspond to those listed in "List 4.3".
Chemicals or products meeting any of these conditions are classified as hazardous substances for household or public health use under Thai FDA supervision. Compliance with specified criteria and procedures for each hazardous substance type is mandatory.
Notification of Type 1 Hazardous Substance
Manufacturers or importers of Type 1 hazardous substances must submit a Product Information Notification Form (Form Wor.Ohr./Sor.Tor.5) along with required supporting documents to the appropriate authority. For domestic production, notification must be submitted within 15 days of initial production. For imports, notification must be submitted before customs clearance of the first shipment.
Location-specific submission requirements:
For manufacturing or storage sites in Bangkok: Submit to the FDA office or via registered mail;
For sites in other provinces: Submit to the respective provincial public health office;
Note: Export and professional use of Type 1 hazardous substances do not require authority notification.
Type 2 and 3 Hazardous Substance Registration
According to the Hazardous Substances Act B.E. 2535 (1992), manufacturers or importers of Type 2 or Type 3 hazardous substances must obtain registration certificates before proceeding with:
Type 2 substances: Manufacturing or import notification;
Type 3 substances: Manufacturing or import licensing;
Exemptions from registration include:
Deodorizers or insect repellents containing naphthalene or p-dichlorobenzene;
Water-based correction products or tape without organic solvents;
Hazardous substance products owned by government agencies;
The registration certificate remains valid for up to six years from the date of issuance.
Required documents for Hazardous Substances Registration
1. Hazardous Substance Registration Application Form (Wor.Ohr./Sor.Tor.1)
2. Product labels
3. Product formula
4. Manufacturing, packaging and labelling processes documentation
5. Physical and chemical properties of hazardous substance product
6. Safety Data Sheet (SDS) for product and all declared ingredients
7. Efficacy test results (for pesticides, disinfectants and bleaches)
8. Certificate of active ingredient content analysis (required for products containing any of the 61 listed hazardous substances subject to quantitative analysis)
9. Certificate of Free Sale (applicable only to imported pesticide products)
Documentation requirements vary depending on the product category: existing hazardous substances, new hazardous substances, technical grade pesticides, pre-mixed pesticides, or finished products. The Hazardous Substances Control Group provides specific Document Checklists for each category.
Hazardous Substance Licensing
Manufacturers and Importers of Type 3 hazardous substances shall register and apply for manufacturing license or import license for such substances. Exporters of registered Type 3 hazardous substances also need to apply for export license.
For those who possess for professional use of Type 3 hazardous substances and have the storage locations in Bangkok, they must submit the application (Form Wor.Ohr.8) to Thai FDA. If the storage locations are in other provinces, the application form must be submitted to the Provincial Public Health Office in that area.
An entrepreneur must submit an application form, namely Hazardous Substance Manufacturing Licensing Application Form, Form Wor.Ohr.1 (แบบ วอ. ๑) (page 29) in case of production, Hazardous Substance Import Licensing Application Form, Form Wor.Ohr.3 (แบบ วอ. ๓) in case of import, or Hazardous Substance Export Licensing Application Form, Form Wor.Ohr.5 (แบบ วอ. ๕) in case of export and the required documents according to the checklists provided by the Hazardous Substances Control Group.