G/TBT/N/THA/719  
29 November 2023  
(23-8073) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  THAILAND  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Thai Food and Drug Administration  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
WTO/TBT Enqui ry Point and Notification Authority  
Thai Industrial Standards Institute (TISI), Ministry of Industry  
Tel.: (662) 430 6831 ext. 2130  
Fax: (662) 354 3041  
E-mail: thaitbt@tisi.mail.go.th  
Website: http://www.tisi.go.th  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addit ion, where applicable):  Type 2 
and type 3 hazardous substances (only for the items under the FDA's responsibility)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Notification of the Ministry of Public Health regarding registrati on, issuance and renewal 
of the registration certificate of hazardous substances under the responsibility of the Food 
and Drug Administration (No. ..) B.E. .…; (4 page(s), in Thai)  
6. Description of content:   
(1) The business operators are required to submit the application and relating documents 
for 
- registration of type 2 and type 3 hazardous substances  
- permission to manufacture or import a sample of hazardous substances in order to 
register such hazardous substances (in case of a quant ity more than 5 kilograms or 5 
liters)  
- self-certification for production or importation of a sample of hazardous substances to 
be registered (in case of a quantity not exceeding 5 kilograms or 5 liters)  
- amendment/change of registration particulars of h azardous substances  
- renewal of the registration certificate  
through the designated electronic system of the Food and Drug Administration (FDA).  G/TBT/N/THA/719  
 
- 2 - 
 
  In the event that submission cannot be completed via the FDA's electronic system, the 
alternative procedures s hall be submitted to the Food and Drug Administration or to the 
designated agency/location/procedure determined by FDA.  
(2) The certificate of registration shall be effective until the last date of the sixth calendar 
year as from the year of the issuance. If there is a necessary ground, the competent 
official shall indicate the validity of the certificate before the specified period.  
(3) A permission to amend any registration particulars of hazardous substances shall be 
noted the amended details in the perm it or issued, in writing, to allow such amendment 
or issued the new certificate of registration.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Improving the registration process by an online submission  
8. Relevant documents:   
- The Hazardous Substances Act B.E. 2535 (1992)  
- Notification of the Ministry of Public Health regarding registration, issuance and renewal 
of the registration certificate of hazardous substances under the responsibility of the Food 
and Drug Administration B.E. 2552 (2009)  
- Notification of the Ministry of Public Health regarding registration, issuance and renewal 
of the registration certificate of hazardous substances under the responsibility of the Food 
and Drug Administration (No. 2 ) B.E. 2558 (2015)  
- Notification of the Ministry of Public Health regarding registration, issuance and renewal 
of the registration certificate of hazardous substances under the responsibility of the Food 
and Drug Administration (No. 3) B.E. 2561 (2018)  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  On the day following the date of its publication in 
the Government Gazette  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
WTO/TBT Enquiry Point and Notification Authority  
Thai Industrial Standards Institute (TISI), Ministry of Industry  
Tel.: (662) 430 6831 ext. 2130  
Fax: (662) 354 3041  
E-mail: thaitbt@tisi.mail.go.th  
Website: http://www.tisi.go.th  
https://members.wto.org/crnattachments/2023/TBT/THA/23_13856_00_x.pdf