Hazardous Substance Registration
Register Hazardous Substances in Thailand for import. A long process that we can do for you.
Siam Trade Development has internal Regulatory Department which provide your HAzardous Substances Registration in Thai FDA, holding your license and managing your stock from the import to delivery.
Hazardous Substances are strictly regulated by the Hazardous Substances Act 1995 and 7 successive amendments.
They are divided into 4 categories depending on risk profile, and registration process, timing and costs depend on classification.
We assist the full process of Hazardous Substances Registration by adding (if necessary) a secure service of License Holding and warehousing for a monthly fee.
Siam Trade Development 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 has less impact on human health and environment than the other types. Class 1 no need registration but a simple notification and labelling. Examples of the type 1 hazardous substances are cleaning products, like dish washing products and laundry detergents.
Type 2 productsmust obtain registration. Examples of type 2 products are Household health pesticides and disinfectants.
Type 3 Substances
The type 3 hazardous substance needs product registration certificate from Thai FDA. Manufacturers, importers, exporters or professional use possessors of type 3 hazardous substances must receive the permission from the authority before the use of such products.
Examples of the type 3 hazardous substances are pesticides containing pyrethroids as active ingredients and cleaning products or disinfectants containing acids, alkalines, or aldehydes.
Type 4 Substances
The type 4 hazardous substance is the hazardous substance with high risks either from its applications or its intrinsic properties, e.g., carcinogens, mutagens, reproductive toxicants or prohibited substances by the related conventions. Manufacturing, import, export or possession of such substances is prohibited.
Examples of the type 4 hazardous substances are DDT, Chlordane, Dieldrin
OUR STANDARD PROPOSAL FOR REGISTRATION OF HAZARDOUS SUBSTANCES
Siam Trade Development register your Hazardous Products in Thailand under your or its own license. Your company shall be indicated as Importer (and shall provide a proper GMP certificate from manufacturer), and will use its venue to be recorder as registered business place in Thai FDA.
After warehouse accreditation has been concluded, Hazardous products shall be registered and label created and applied to the packaging.
After import procedure has been terminated the product shall be stored and delivered to end user (in case of e-commerce for Type 1 and 2 Hazardous Substances) or passed to the distributor/user (in case of Type 3 or 4).
Time for Hazardous Products registration is from 4 to 8 months. If you don’t have a local unit Siam Trade Development can register your own Company in Thailand and make it fully licensed.
GENERAL GUIDELINES FOR HAZARDOUS SUBSTANCES REGISTRATION IN THAILAND
The type of hazardous substance is considered by the product’s ingredient. We have to check each ingredient of the product in the FDA database system for considering its type. In case there are several ingredients, and type for each ingredient is different, the product will be defined as a type of the most hazardous ingredient in the product.
For FDA Thailand, products are considered as hazardous substances depending on their purpose.
The Hazardous Substance Act B.E. 2535 (1992) classifies hazardous substances into 4 types. The names of hazardous substances, types of hazardous substances, responsible agencies and conditions of control are publicized in the annexed table of the Notification of Ministry of Industry on List of Hazardous Substances.
Steps for checking your Hazardous Products
The primary steps to check any chemical or any product is a hazardous substance under the responsibility of Thai FDA, are listed as follows:
1. Checking whether the product’s active ingredients match to any of chemicals listed in “List 4.1” and its use corresponds to the conditions specified in “List 4.1”.
2. Checking whether the product’s active ingredients are a substance in any of chemical groups listed in “List 4.2” and its use corresponds to the conditions specified in “List 4.2”.
3. Checking whether the use of product or product claims match to any of those in “List 4.3”.
Chemicals or products that fall in any mentioned conditions are classified as hazardous substances used in household or public health under the responsibility of Thai FDA. Consequently, compliance to the specified criteria and procedures for each type of hazardous substances is required.
Notification of Type 1 Hazardous Substance
Manufacturers or importers of type 1 hazardous substances must notify the information of hazardous substance products to the authority by submitting an application form, namely Notification of Product Information of Type 1 Hazardous Substance Wor Ohr./Sor Tor 5 (วอ./สธ ๕) (page 13), and the required documents stated in the form. In case of production, the information must be notified to the authority within 15 days since the first production date. Only the first import, the information must be notified to the authority before clearing shipment at the customs. If the manufacturing or storage sites of type 1 hazardous substance are located in Bangkok, the manufacturers or the importers must notify at the FDA office or by registered mail. If the manufacturing or storage sites of type 1 hazardous substance are located in other provinces, the manufacturers and the importers must notify at the provincial public health office where the sites are located. Export and possession for professional use of type 1 hazardous substances are not required to notify the authority.
Type 2 and 3 Hazardous Substance Registration
According to The Hazardous Substances Act B.E. 2535 (1992), the manufacturers or the importers of type 2 or type 3 hazardous substances need to obtain the registration certificates prior to the further actions such as notifying their manufacturing or import of the type 2 hazardous substance or obtaining the license of manufacturing or import of the type 3 hazardous substance. Nevertheless, there are some exemptions for some hazardous substance products that are not required for registration such as deodorizers or insect repellents containing naphthalene or p-dichlorobenzene as an active ingredient, paper correction products in the forms of water-based solution or tape without organic solvents, and hazardous substance products belonging to the government agencies. The registration certificate shall be valid for a period not exceeding six years from the date of issuance.
Required documents for Hazardous Substances Registration
1. Hazardous Substance Registration Application Form Wor Ohr./Sor Tor 1 (วอ./สธ ๑)
2. Product labels
3. Product formula
4. Manufacturing, packaging and labelling processes
5. Physical and chemical properties of hazardous substance product
6. Safety data sheet (SDS) of product or of all ingredients declared in the product formula
7. Efficacy test result (in case of pesticides, disinfectants and bleaches)
8. Certificate of analysis of active ingredient content (in case of the product contains any hazardous substance on the list of 61 hazardous substances that require the quantitative analysis of active ingredients)
9. Certificate of free sale (only the imported products of pesticides)
There are some differences of data requirements for registration of existing hazardous substances, new hazardous substances, technical grade pesticides, pre-mixed pesticides, and finished products. Therefore, the Hazardous Substances Control Group has provided the Checklist of Required Documents for Hazardous
Hazardous Substance Licensing
Manufacturers or 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 substance 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 impor, 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.