What are Hazardous Substances?

Definition and classification of hazardous substances according to the Hazardous Substances Act, B.E. 2535 (1992)

Under the Hazardous Substances Act, B.E. 2535 (1992), a "hazardous substance" is defined as any substance possessing any of the following characteristics: 

1) explosive substances;

2) flammable substances;

3) oxidizing substances and peroxide substances;

4) toxic substances;

5) pathogenic substances;

6) radioactive substances;

7) mutagenic substances;

8) corrosive substances;

9) irritant substances;

10) other substances, be it chemical or otherwise, which may be harmful to persons, animals, plants, properties, or the environment.

For the purpose of preventing and suppressing harm that may occur to persons, animals, plants, properties, or the environment caused by hazardous substances, the Hazardous Substances Act classifies hazardous substances into 4 distinct types based on the severity of their impact and the need for regulation:

Type 1 Hazardous Substance, a hazardous substance with a lower severity of impact than other groups, for which the law does not require the manufacturer or importer to register the substance. However, any manufacturer, importer, exporter, or possessor of such substances must comply with prescribed rules and procedures. These include labeling requirements and guidelines for manufacturing and storage. Furthermore, manufacturers and importers of Type 1 Hazardous Substances regulated by the Thai FDA must submit a detailed declaration to the competent officer prior to initial production or importation.

Type 2 Hazardous Substance, a hazardous substance that poses a higher level of harm or risk than a Type 1 Hazardous Substance, which must be registered by the manufacturer or importer. Furthermore, manufacturers, importers, exporters, and possessors must notify the competent officer prior to commencing operations.

Type 3 Hazardous Substance, a hazardous substance that poses a higher level of harm or risk than Type 1 and Type 2 Hazardous Substances, which must be registered by the manufacturer or importer. Furthermore, after receiving a registration certificate, manufacturers, importers, exporters, or possessors must obtain a license from the competent officer before commencing operations.

Type 4 Hazardous Substance, a hazardous substance that poses a high level of harm or risk due to both the nature of the substance itself and its manner of use—such as a carcinogen, mutagen, reproductive toxicant, or any substance prohibited by international conventions. Consequently, the law strictly prohibits the manufacture, import, export, transit, or possession of such substances.

According to the Hazardous Substances Act B.E. 2535 (1992), regulated hazardous substances are designated in the Hazardous Substances List, annexed to the Notification of the Ministry of Industry Re: List of Hazardous Substances. The issuance or amendment of this list is subject to the review and approval of the Hazardous Substance Committee. In practice, a sub-committee consisting of qualified members, representatives of government agencies, and representatives of private organizations considers the matter and forwards the result to the Hazardous Substance Committee. This facilitates the announcement of such chemical or product in the hazardous substances lists via a Notification issued by the Ministry of Industry, with the Department of Industrial Works acting as the main secretariat. Such Notification will clearly specify the name or properties of the hazardous substance, type of hazardous substance, and conditions for hazardous substance control, as well as its responsible agency.

Currently, 6 agencies are responsible for regulating hazardous substances under the Hazardous Substances Act. Their mandates are divided based on each agency's mission and the intended use of the substances, as follows:

1. Department of Agriculture, regulating substances used in agriculture;

2. Department of Fisheries, regulating substances used in fisheries and aquaculture;

3. Department of Livestock Development, regulating substances used in livestock farming;

4. Food and Drug Administration, regulating substances used in households or public health;

5. Department of Industrial Works, regulating substances used in industries;

6. Department of Energy Business, regulating petroleum-based hazardous substances."

Hazardous substances under the responsibility of Food and Drug Administration

The names, types, and control conditions of hazardous substances under the responsibility of the Food and Drug Administration (FDA) are specified in List 4, annexed to the Notification of the Ministry of Industry Re: List of Hazardous Substances, which comprises the following three sub-lists:

1. List 4.1: Specifies hazardous substances according to the chemical list.
2. List 4.2: Specifies hazardous substances according to chemical groups with similar structural formulas or mechanisms of action.
3. List 4.3: Specifies hazardous substances according to product groups or purposes of use.
   

To determine whether a product falls within the scope of an FDA-regulated hazardous substance, please follow these steps:

1. Check if the product contains an active ingredient that matches the chemical list and Chemical Abstracts Service number (CAS No.) and ensure its purpose of use aligns with the conditions in List 4.1.
2. Check if the product contains an active ingredient within the specified chemical groups and ensure its purpose of use aligns with the conditions in List 4.2.
3. Check if the product's purpose of use or product claims comply with the conditions prescribed in List 4.3.

You can check the list of Type 1, Type 2, or Type 3 hazardous substances—as notified in the product notification for Type 1 hazardous substances or registered as Type 2 or Type 3 hazardous substances —via this link: https://moph.link/activeingredientlist

If the substance cannot be found in the above list, or if you have any questions, please submit a request for hazardous substance classification or analysis through e-Submission.