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On June 28, 2023, Thailand’s Food and Drug Administration (FDA) notified WTO of the proposed updates of the notification requirements for Type 1 hazardous substances (only for items under the FDA’s responsibility) for comments. Thailand’s current regulation regarding this issue is the Notification of the Ministry of Public Health Re: Notification of Fact Relating to Type 1 Hazardous Substances Under the Responsibility of the FDA B.E. 2562 (2019). Once the proposed updates are adopted and come into force, the 2019 version will be repealed. New regulation is expected to take effect after 180 days from the date of its publication in the Government Gazette. Comments are welcome before September 8, 2023.
Proposed updates
Adding new requirements to enhance the notification process
After receiving the notification receipt, manufacturers and importers of Type 1 hazardous substances should confirm the fact (e.g., chemical name, concentration, hazard property) relating to the target hazardous substances to the authority every six years. In other words, if a manufacturer or importer initially notified the authority of their production or importation of Type 1 hazardous substances in a certain year, they would need to confirm that fact every 6 years thereafter, using the new form provided by the authority, and do so by January 31 of the following year after the 6-year period has elapsed (i.e., the 31st of January of the 7th year. In case of non-compliance with the aforementioned confirmation requirement, enterprises shall conduct the re-notification to the authority.
Updating the forms concerning chemical notification
"Wor Or./Sor Thor 5" (the notifying form for manufacturing and importing of Type 1 hazardous substances) shall include an additional field for "English tradename (if any)".
"Wor Or./Sor Thor 16" (the amending form in case of changing the details in Wor Or./Sor Thor 5) shall include 2 additional fields for "English tradename (if it was not previously notified in Wor Or./Sor Thor 5)" and "Characteristics of the product".
More details can be accessed here (WTO Notification No. G/TBT/N/THA/705).
Background
In Thailand, chemicals in the List of Hazardous Substances under the Hazardous Substances Act B.E. 2535 (1992) are subject to notification, registration, or permit/license, etc., according to the hazard type (Type 1 ~ Type 4). The List consists of 6 annexes, which are separately regulated by different authorities. Annex 4 is under the FDA’s responsibility. The updates proposed this time are aimed at improving the notifying procedure and the details in the forms relating to notifying the fact of Type 1 hazardous substance in Annex 4 (see here).
