Chemical Compliance
Intelligence & Solutions
Thailand Chemical Substance Act (Draft)
Jul 20, 2022
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CONTENTS

Overview

Currently, the management of hazardous substances in Thailand is implemented in accordance with the Hazardous Substance Act (HSA) released by the Department of Industrial Works (DIW), which is the most important chemical management regulation in Thailand. However, the HAS is not comprehensive enough to cover the complexities inherent in chemical management in Thailand nor can it effectively control hazardous chemicals throughout their lifecycle and the supply chain.

In 2019, a draft new chemical regulation named Chemical Substance Act was released by the Thailand IPCS under the Food and Drug Administration (FDA). This draft covers the whole chemical lifecycle, i.e., manufacturing, importation, exportation, transportation, transit, re-import, re-export, to processing, sale, distribution, use, treatment, and disposal of chemical substances and mixtures, as well as recycling.

According to some existing reports, once the Chemical Substance Act is approved, it will replace the Hazardous Substance Act to control chemicals in Thailand.

First draft issued in April 2019

On April 26, 2019, the first draft of the Chemical Substance Act was released and discussed for public comments at a seminar held by the government.

The new Act contains these parts: 

  • The foundation of the National Chemical Policy Committee, Chemical Assessment Committee (CAC), Specific Sector of Chemical Management Committee and National Chemical Agency and their qualification, power and responsibilities.

  • Chemical management process. In this part, chemicals are sorted into three lists and requirements for chemicals in each list are detailed, as well as the provisions on chemicals assessment, qualification, control, and inspection.

  • Measures to promote and support chemical management. It stipulates that the Chemical Information Centre under the National Chemical Agency will be responsible for the preparation and dynamic update of the Thailand chemical inventory.

  • Duties and penalties. The insurance and compensation for the damages resulting from chemicals are emphasized.

  • Transitional measures. 

In the Chemical Substance Act, Thailand’s focus on chemicals management has shifted to management based on risk. In the new Act, substances will be classified into 3 Lists with reference to Thailand Existing Chemical Inventory and risk assessment conducted by the CAC. Here are the descriptions of the substances in these three Lists: 

List 1: Low risk. Enterprises shall comply with the coming standards regarding import/export, production, transportation, storage and disposal/recycling of substances in List 1.

List 2: High risk. Enterprises must obtain licensing from the competent authority before handling chemicals in this list.

List 3: All activities are prohibited, while substances used for R&D purposes or chemicals where contamination at use is unavoidable with controlled risk may be exempt. 

The review of the chemicals in the hazardous substance list of HSA and Thailand's existing inventory from the current classification system to the new system under the Chemical Substacne Act will also be conducted by CAC, as specified in the transitional provisions. Here are other proposed transitional provisions: 

  • The notification or registration which was applied under HSA but still in process would be transferred to the new act.

  • The existing permits and qualifications under HSA will still be valid until expiration.

  • The ministerial regulations and notices under HSA will still be effective until the new ones under Chemical Substance Act are approved. 

Besides the points mentioned above, here are some other developments in the new act: 

  • The new act covers the entire chemical life cycle and regulates not only substances but also mixtures and articles.

  • The validity period of licenses is specified and shall not exceed 6 years.

  • The insurance and compensation for the damages arising from chemicals are regulated, and the penalty scheme will be stricter. 

Second draft issued in September 2019

Only five months after the first draft, the second draft of the Chemical Substance Act was released on September 3, 2019. In this version, many provisions have been adjusted to be more applicable and practical. The most important amendments are shown as below:

  • The Only Representative system is proposed. Oversea manufacturers shall appoint a qualified representative to conduct the registration process according to the second draft. And the representative must be a Thai national, have an office in Thailand and have obtained relevant qualifications.

  • The second draft clearly states that CAC has to sort the substances in the Hazardous Substance List and other related lists into the three new lists within one year from when the CSA comes into effect.

  • Requirements for the members of the Committees have been revised. The power and responsibility of the Committees have been adjusted as well.

Latest version (fourth draft) issued in January 2021

On January 7, 2021, the FDA published the fourth draft of the Chemical Substance Act. Compared with the second version, which is the last public draft, the fourth draft consists of 108 articles. The number of the articles of the section ‘Legal Responsibilities’ has increased from 13 to 18. The fourth draft clarifies many details in the registration, evaluation of chemical substances, and the responsibilities of administrations and enterprises, while the framework for chemical management is not changed a lot. Important changes in this draft are shown as followings.

For the sections of chemical evaluation and authorization in the new draft, adjustments to many provisions are made and several new articles are added:

  • An exemption condition is confirmed, i.e., the specific group, class, or type of chemicals that approved by the Chemical Assessment Committee (CAC) can exempt from the Chemical Substance Act.

  • Two modifications involving the chemical inventory were made. In Article 34, for the classification of chemical substances, the inventory shall be issued in accordance with the classification results. And in Article 35, the CAC is required to publish relevant information on the changes of the chemical inventory.

  • For the management of only representative, the appointment and canceling shall report to FDA. Ministry of Public Health will formulate a Ministerial Regulation on the rules, procedure, qualification review for a representative appointment, as well as the suspension, renewal, and revocation of an appointment, etc.

  • The Minister of the Ministry of Public Health shall also specify the registration fee, evaluation fee, and the representative fee in a Ministerial Regulation. The fees charged will include the costs for hiring external experts to conduct chemical assessments and for handling chemical accidents in the future.

Significant changes are also made to the section Legal Responsibilities. In addition to the supplement of new specifications for violations on the operation of new chemical substances, penalties for other violations have also been adjusted.

For the transitional provisions, an article for materials which are not or may not be chemicals, such as microorganisms, microbial products, or plant exacts, etc. is added. Such materials shall be, if they have been declared as hazardous substances under the Hazardous Substance Act, subject to the Chemical Substance Act until other regulations for them are implemented.

Conclusion

The draft Thailand Chemical Substance Act has been formulated based on the Hazardous Substances Act and the advanced chemical control regulations of other regions, especially EU REACH. This new act is not only a more complete and efficient chemical control regulation it has also been developed to meet Thailand's specific requirements. The upcoming registration and assessment responsibilities for chemicals are clear in the latest version, and relevant guidelines shall be issued by the administrations for the implementation of the Chemical Substance Act. The timeline for implementation of the new regulation has not been stipulated yet but when finalized it will undoubtedly have major implications for stakeholders.