This is a comprehensive guide on regulations regarding hazardous substances in Thailand for businesses.
Hazardous substances are chemicals or substances that are harmful to people, animal or the environment. As a result, there are certain limitations to the type of substances that can be manufactured, imported, exported or possessed.
Let’s find out more about hazardous substances.
What is a hazardous substance?
Under the Hazardous Substance Act, hazardous substances include the following:
- Corrosive substances
- Disease-causing substances
- Inflammable substances
- Irritative substances
- Mutagenic substances
- Oxidising agents and peroxide substances
- Radioactive substances
- Toxic substances
Types of hazardous substances
Hazardous substances are categorised into four types in Thailand, which are:
- Type 1 – hazardous substances that have a less hazardous impact on human health and the environment
- Type 2 – hazardous substances that are more hazardous than type 1
- Type 3 – hazardous substances more hazardous than type 2
- Type 4 – highest degree of hazardous risks (prohibited)
Hazardous substance type 1
Manufacturers and importers of type 1 hazardous substances are not required to register their products, but they must notify the authorities about the product information.
Business operators must comply with the specified criteria and procedures, such as labelling, rules and conditions for manufacturing and storing.
Examples of type 1 hazardous substances are:
- Cleaning products, such as dishwashing products, liquid laundry detergents containing anionic or nonionic surfactants as active ingredients (except nonylphenol ethoxylate)
- Adhesives containing alkyl cyanoacrylate as active ingredients
- Swimming pool disinfectants containing calcium hypochlorite, sodium hypochlorite, Dichloroisocyanuric acid and its salts or trichloroisocyanuric acid and its salts as active ingredients
Hazardous substance type 2
Manufacturers and importers of type 2 hazardous substances must have registration certificates. Manufacturers, importers, exporters or professional use possessors of type 2 hazardous substances must notify the competent authorities before the operations of type 2 hazardous substances. The registry number must be listed on the product label.
Examples of type 2 hazardous substances are:
- Household and public health pesticides containing insect growth regulators as active ingredients
- Cleaning products/disinfectants (except any products containing type 1 or 3 hazardous substances as active ingredients)
Hazardous substances type 3
Manufacturers and importers must obtain product registration certificates. Manufacturers, importers, exporters or professional use possessors must obtain a license from the authorities before operations of type 3 hazardous substances. The hazardous registry number must be stated on the product label.
Examples of type 3 hazardous substances are:
- Household and public health pesticides containing chlorpyrifos or pyrethroids as active ingredients
- Cleaning products/disinfectants containing acids, alkalines or aldehydes as active ingredients
Hazardous substances type 4
The production, import, export or having in possession is prohibited.
Examples of type 4 hazardous substances are:
- Dichlorodiphenyltrichloroethane (DDT)
Type 1 hazardous substance product information notification
Notification of type 1 hazardous substances include the following:
- Manufacturers or importers – must notify the product’s information to the authority by submitting the Notification of Product Information of Type 1 Hazardous Substance Form (Wor Ohr./Sor Tor 5) together with a copy of the identification card in case of a natural person or a copy of the certificate of juristic entity registration and a copy of power of attorney.
- Production – information must be notified to the authority within 15 days of the first production date
- First import – information must be notified to the authority before clearing shipment at the customs
- Manufacturing or storage sites –
- Located in Bangkok: manufacturers or importers must notify at the FDA office
- Located in other provinces: manufacturers or importers must notify at the provincial public health offices
- Export and possession for professional use – not required to notify the authority
Hazardous substance registration
Manufacturers and importers of type 2 and 3 hazardous substances must obtain registration certificates before notifying the manufacturing or importing of type 2 hazardous substances or obtaining the license to manufacture or import type 3 hazardous substances.
The registration certificate is valid until 31 December of the sixth year of issuance.
The registration fee and renewal fee is THB 2,000.
Required documents for hazardous substances registration
To register hazardous substances, you will need the following documents:
- Hazardous Substance Registration Application Form (Wor Ohr./Sor Tor 1)
- Product labels
- Product formula
- Manufacturing, packaging and labelling processes
- Physical and chemical properties of hazardous substance product
- Safety data sheet (SDS) of product or all ingredients declared in product formula
- Efficacy test result (pesticides, disinfectants and bleaches)
- Report of analysis of active ingredient content (61 hazardous substances that require the quantitative analysis of active ingredients)
- Certificate of free sale (only for imported pesticide products)
- Certified letter confirming that the FDA has registered the product
Type 2 hazardous substance notification
Notification of type 2 hazardous substances include the following:
- Manufacturers or importers – must obtain the product registration certificate and notify the production or import of the type 2 hazardous substance to the authority
- Exports or possessors for professional use – must notify the export or possession of Thai FDA-registered products to the authority
- Possession for professional use – must notify at the FDA office (Bangkok) or the provincial public health office (other provinces)
When notifying the authorities, the Type 2 Hazardous Substance Operation Notification Report Form (Wor Ohr./Sor Tor 3) must also be submitted along with the following documents:
- Copy of certificate of juristic entity registration or identification card with a copy of the commercial registration (if any) in case of a natural person
- Power of attorney (if required)
- Copy of hazardous substance registration certificate
- Sketch map of the enterprise location and neighbouring area
- Layout of the enterprise building
- Documents showing expertise of experts or personnel responsible for the operation
Type 3 hazardous substance licensing
Manufacturers or importers must register and apply for a manufacturing license or import license. Exporters also need to apply for an export license.
Type 3 professional use possessors and those who have storage sites in Bangkok must submit an application form (Form Wor Ohr. 8) to the Thai FDA. For storage sites in other provinces, the application form must be submitted to the provincial public health office.
The following applications must be submitted:
- Manufacturing – Hazardous Substance Manufacturing Licensing Application Form (Wor Ohr. 1)
- Importing – Hazardous Substance Import Licensing Application Form (Wor Ohr. 3)
- Exporting – Hazardous Substance Export Licensing Application Form (Wor Ohr. 5)
The license is valid until 31 December of the third year of issuance.
Fees for the manufacturing, import or export license are:
- THB 500 for less than 10,000 kilograms
- THB 1,000 for 10,001 kilograms to 50,000 kilograms
- THB 1,500 for 50,001 kilograms to 100,000 kilograms
- THB 3,000 for 100,001 kilograms and more
The fee for the possession license is THB 500 for less than 10,000 kilograms a year and less than 500 square metres of the specified storage area.
To engage in any business concerning hazardous substances in Thailand, you must ensure you follow the regulations laid out by the relevant authorities. To assure you comply with the rules and regulations regarding hazardous substances, we recommend engaging with Acclime’s legal services.