Thailand FDA to Further Standardize the Management on Transit of Hazardous Substances

FDA drafted a notification to specify the application, approval and change of transit license of hazardous substances for the better implementation of relevant requirements in HSA No.4. The consultation period will conclude on December 15th, 2020. The application and permission forms are provided as attachments for enterprises to refer to.

On November 3rd, 2020, WTO issued a notification ^[1] to notify members on Thailand’s Notification of the Food and Drug Administration RE: criteria, procedures and conditions for the notification, requesting permission, and issuance of the transit license relating to hazardous substances under the responsibility of the Food and Drug Administration and request comments on it. The consultation will conclude on December 15th, 2020.

The “transit” of hazardous substances were specified in Hazardous Substance Act No.4, which came into effect in October of 2019. Transit refers to when commodity enters Thailand and then is transferred out of the country within a few days.

According to the HSA No.4,

for Type 1 and 2 hazardous substances, notification of authorities is required prior to each transit, and
for Type 3 hazardous substances, permission should be obtained in advance.

A transit license will be issued for those that have completed notification or those that have obtained permission in advance of transit. Transit of Type 4 hazardous substances is prohibited. (ChemLinked News ^[2])

The draft notification consists of 3 Chapters,

(1) Chapter 1 General Provisions,

Create new forms for all needed operation of both enterprises and authority
Setting the qualification of hazardous substances’ transporter
Setting the criteria, procedures and conditions of the transit guarantee

(2) Chapter 2: Setting the criteria, procedures and conditions for approval for transit license

(3) Chapter 3: Setting the criteria, procedures and conditions for changing context and detail on the transit license

The new forms are provided as attachments to the notification, including

"Wor Or./Sor Thor 19" for making the contract of guarantee for transit operation,
"Wor Or./Sor Thor 20" for notifying the transportation of type 1 and 2 hazardous substances through Thailand,
"Wor Or./Sor Thor 21" for submitting the transit application for type 3 hazardous substances, and
"Wor Or./Sor Thor 22" for granting permission of the transportation of type 3 hazardous substances through Thailand.

Note that the FDA Notification on transit only applies to the hazardous substances for which FDA is responsible. As for the List of Hazardous Substances, FDA is in charge of List 4, which consists of 3 sub-lists for now, which are the following:

4.1: List of controlled substances
4.2: List of controlled substance groups
4.3: List of controlled product groups

Furthermore, the Thailand Department of Industrial Work (DIW), has issued the notice to regulate the transit of List 5 hazardous substances last December (ChemLinked News ^[3]). Although the requirements and procedure are similar, stakeholders shall pay attention to the need to use different forms. The FDA Notification is proposed to be adopted and come into force this December, and Chemlinked will report on it post-haste.