1. Overview

Since 1960, Thailand has been committed to the control of hazardous materials, particularly dangerous chemicals. The Hazardous Substance Act (HSA) of Thailand, established in 1992, serves as the foundational legal framework for managing hazardous chemicals in the country. Administered by the Department of Industrial Works, it regulates activities including the production, import, export, sale, storage, and usage of hazardous substances to ensure public safety and environmental protection. The HSA lacks comprehensiveness and is somewhat outdated, failing to effectively manage the complexities of chemical regulation. It inadequately controls the life-cycle and supply chain of hazardous chemicals and falls short of aligning with international standards. Thailand continues to face significant challenges under its current chemical regulations, including consumer impacts, health issues, environmental persistence of chemicals, and illegal dumping. Moreover, chemical-related businesses experience substantial obstacles under the existing HSA framework.

In 2019, Thailand's Food and Drug Administration (FDA) proposed the Chemical Substance Act (CSA), aimed at regulating the full life-cycle of chemical substances including their production, import, export, and disposal. The Act, intended to replace the existing Hazardous Substances Act, will comprehensively manage chemical controls in Thailand. The government has released four drafts of this legislation so far.

2. The First Draft of Chemical Substance Act

The first draft of the Chemical Substance Act was unveiled in a notice on April 23, 2019. Three days later, it was openly discussed at a workshop organized by the FDA, where public feedback was solicited.

The new Act is composed of the following sections:

(1) Establish National Chemical Policy Committee, Chemical Assessment Committee, Chemical Management Committee, and National Chemical Agency, with clearly defined responsibilities for each department.

• National Chemical Policy Committee: The highest decision-making body, led by the Prime Minister or Deputy Prime Minister, is responsible for developing policies and strategies for chemical management. This body is also tasked with submitting an annual national chemical status report to the Cabinet.
• Chemical Assessment Committee (CAC): Comprised of representatives from relevant agencies and members with appropriate professional qualifications, this body is tasked with establishing standards for chemical registration, compiling an existing chemical inventory in Thailand, classifying chemicals and setting related standards, communicating chemical risk information to the public, and conducting chemical assessments.
• Specific Sector of Chemical Management Committee: In the sectors of agriculture, public health, industry, and others, this body defines the standards, methods, terms, and conditions for chemical management based on a chemical inventory list. It also determines the standards, procedures, terms, and conditions for issuing chemical permits and is responsible for public communication regarding chemical risks.
• National Chemical Agency: In the sectors of agriculture, public health, industry, and others, this agency defines the standards, methods, terms, and conditions for chemical management based on a chemical inventory list. It also determines the standards, procedures, terms, and conditions for issuing chemical permits and is responsible for public communication regarding chemical risks.

(2) The management of chemicals involves processes such as assessment, licensing, control, and monitoring. Chemicals are classified into three lists by committee based on health and environmental risk assessments.

• List 1: Low risk. Businesses must adhere to the standards, methods, timelines, and conditions specified in the regulations or notices issued by the CAC, the Specific Chemicals Committee, and/or the responsible minister.

• List 2: High risk. Businesses must secure permits adhering to specific regulations before engaging with chemicals listed in the inventory. These regulations are defined by various committees and ministers and are categorized based on the intended chemical use. List 2 is divided into three sub-lists based on the intended use of the chemicals.

List 2.1: For agricultural purposes, upon approval, it will be listed under list 2.1.

List 2.2: For public health purposes, upon approval, it will be listed under list 2.2.

List 2.3: For industrial and other purposes, upon approval, it will be listed under list 2.3.

• List 3: Prohibited chemicals. All activities related to the chemicals listed in this inventory are prohibited, including import, export, and use, among others. Exceptions may be made for chemicals used in research and development or those that cause unavoidable, less hazardous pollution.

(3) Promote and support measures for chemical management. The Chemical Information Center under the National Chemical Agency will be responsible for compiling and continuously updating the existing list of chemicals in Thailand, establishing a database of registered operators and chemicals, as well as databases related to chemical assessments and data on chemicals from various lists.

(4) Responsibilities and obligations, including civil and criminal liabilities, are clearly defined. The Act specify compensation and penalties for violations of chemical management provisions.

(5) The committee will assess and update Thailand's chemical inventory, including those under the HSA and lists from other agencies. The transitioning to a new classification system within 180 days post-law enactment, extendable to one year. Other transitional provisions are as follows:

1. The notification or registration under HSA that are still in progress may be transferred to the new act.
2. Permits and registration qualifications obtained under HSA will remain valid until their expiration.
3. Regulations and notifications previously issued under HSA will continue to be valid until Chemical Substance Act are approved, unless they conflict with the provisions of the new regulations.

In addition to the aforementioned points, the new Act also introduces several other significant changes:

• The current classification system under the HSA divides chemicals into four hazard categories, whereas the Chemical Substance Act organizes them into three categories listed across three distinct lists.
• The regulatory scope now extends across the entire lifecycle of chemicals, covering everything from production to disposal, including the import, export, distribution, and recycling of substances, mixtures, and articles.
• The validity of licenses for chemicals in List 2 is limited to a maximum of six years, and companies with revoked licenses cannot apply for a new one for five years.
• Chemicals that are not included in the existing list of chemicals in Thailand are considered new chemicals, and companies must submit a request for assessment to the Chemical Evaluation Committee and provide the required information before engaging in related activities.
• The new Act establishes insurance and compensation mechanisms for damages caused by chemicals, with stricter penalties enforced.

3. The Second Draft of Chemical Substance Act

The second draft of the Chemical Substance Act was released on September 3, 2019. Following this, the FDA held a public hearing on October 21, 2019, to discuss the draft with representatives from various sectors, including the public, private, academic, and NGOs. The draft was significantly revised to improve its applicability and practicality, with key modifications to several provisions：

• The CSA's second draft mandates that foreign manufacturers must appoint a qualified Only Representative (OR) in Thailand to handle registration. This representative should be a Thai national with an established local office.
• The responsibilities of the CAC are to assess and revise Thailand's chemical inventory within a year of the CSA's implementation. This includes integrating existing chemicals from various lists into three new inventories.
• Budget and roles for committee members have been updated.

4. The Third Draft of Chemical Substance Act

The third draft of the Chemical Substance Act is not publicly available yet.

5. The Forth Draft of Chemical Substance Act (Latest Version)

On January 7, 2021, the Committee of Chemical Policy Development in Thailand released the fourth draft of the Chemical Substances Act, which was published on the official website of the FDA under the Ministry of Public Health (MOPH).

The fourth draft, now comprising 108 articles, refines the framework for chemical management by updating regulations on assessment, licensing, and the roles of regulatory agencies and enterprises to enhance the regulatory system. The primary changes in this draft are as follows:

• Chemical Exemptions: Specific chemicals can be exempted from the regulation’s mandatory requirements if approved by the CAC based on their classification.       
• Chemical Inventory: The inventory is published according to chemical classifications, with updates on changes required to be made public by the CAC.
• Management of Only Representatives (ORs): The appointment or dismissal of an Only Representative must be reported to the FDA. The Ministry of Public Health is tasked with establishing regulations that define the criteria, procedures, and conditions for the appointment of ORs. These regulations also detail the qualifications and duties of ORs, as well as the processes for application, issuance, renewal, suspension, and revocation of OR licenses.
• Fee Regulations: The Minister of Public Health will detail fees for registration, chemical assessments, and OR licensing in ministry regulations, covering costs for expert consultations and future chemical incident management.
• Legal Responsibilities: The "Criminal Liability" section has been expanded from 13 to 18 articles, incorporating new regulations on the mishandling of novel chemical substances, alongside revised penalties for various regulatory violations.
• Transitional Provisions: New clauses address the regulation of non-chemical substances, like microorganisms and plant extracts, enforcing current Act until further legal frameworks are developed.
• Label Management: The draft clarifies that committees responsible for agricultural, public health, and industrial chemicals will handle label management duties.
• Regulatory Agency Responsibilities: More authority is vested in the Food and Drug Administration and the Ministry of Health, with the former acting as the law's implementing secretariat rather than creating a new chemical regulatory agency. Foreign manufacturers must designate representatives through the FDA to be their authorized agents.

Overall, the fourth draft significantly enhances chemical management, specifies the responsibilities of regulatory bodies and companies, and improves the detail of legal responsibilities.

6. Conclusion

The proposed Chemical Substances Act in Thailand is an enhancement of the existing Hazardous Substances Act, integrating elements from the EU’s REACH regulations and other global best practices in chemical management. This updated framework aims to enhance the efficiency and comprehensiveness of chemical control in Thailand, fostering sustainable industry practices and ensuring safety. The act specifies responsibilities for chemical registration and assessment, with regulatory standards and guidelines to be issued by the appropriate administrative.

This act introduces a novel requirement for foreign chemical manufacturers to designate a resident agent in Thailand as their only representative, a stipulation not yet established in the existing HSA. Furthermore, it sets a precedent by extending regulatory measures to include non-hazardous chemicals, thereby filling a regulatory void not addressed by the current HSA.

The enactment date for the draft Chemical Substances Act is still pending as government agencies evaluate its impacts and industry readiness for compliance. If approved, this legislation will substantially transform chemical regulation in Thailand, affecting numerous stakeholders. Companies dealing with chemical import and production should stay informed about these developments and prepare for potential changes.

Prior to the enactment of the new law, the oversight of industrial chemicals remains governed by the Hazardous Substances Act and the accompanying List of Hazardous Substances. Companies engaged in the import or manufacture of chemicals are required to check if the substances involved are included on the List of Hazardous Substances and to accurately determine their hazard classifications. This is essential to meet the stipulated requirements for notification, registration, and/or licensing.