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On January 7th, 2021, Thailand IPCS under the Food and Drug Administration (FDA) published a draft of the Chemical Substance Act [1], which is the 4th one. The first draft of the Chemical Substance Act was published in 2019, and once the Act is finalized and enforced, it will replace the Hazardous Substance Act to manage the chemical substances in Thailand (ChemLinked News [2]). Please refer to this article [3] to learn more about the new Act: Understanding the Brand New Thailand Chemical Substance Act.
For the sections of chemical evaluation and authorization in the new draft, adjustment to many provisions are made and several new articles are added. Important changes as shown as followings:
An exemption condition is confirmed, that 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. For this section, compared with the 2nd draft, which was the last public draft, the number of articles has increased from 13 to 18. 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.
In general, compared with the previous two drafts, the 4th 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. The upcoming registration and assessment responsibilities for chemicals are clear, and relevant guidelines shall be issued by the administrations for the implementation of the Act. For now, we shall expect a national inventory of existing chemical substances and the Chemical Substance Act to be finalized, and ChemLinked will report on it post-haste
