G/SPS/N/THA/235  
 
4 February 2016  
(16-0751)  Page: 1/3  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
1. Notifying Member: THAILAND 
If applicable, name of local government involved:   
2. Agency responsible: Food and Drug Administration (Thai FDA) 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S numbers should be provided in 
addition, where applicable): Novel food (ICS Codes: 67.020, 67.040) 
4. Regions or countries likely to be affected , to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document: Draft Ministry of Public Health Notification, No. .... 
B.E. .... (....) entitled "Novel food"  Language(s): Thai  Number of pages: 5 
http://members.wto.org/crnattachments/2016/SPS/THA/16_0397_00_x.pdf  
6. Description of content: The Ministry of Public Health (MOPH) considered that novel 
ingredients which have never been used fo r consumption as food or used as food 
ingredients as well as novel process that never been used earlier for production of food. 
Therefore, the notification of MOPH entitled  "Novel food" has been issued for providing 
risk assessment measure in order to protect consumer as follows:  
Clause 1 - Novel food in this notification means: 
1) Any object used as food or food ingredients which have been significantly used 
for human consumption less than fifteen years based on scientific or reliable evidence; or 
2) Any object used as food or food ingredients to which has been applied a 
production process not currently used, where that process gives rise to significant changes in the composition or structure of such food which affect their nutritional value, metabolism or level of undesirable substances; or 
3) Any food product contains either 1) or 2) as an ingredient. 
However, food additives and food obtained  through certain techniques of Genetic 
Modification/Genetic Engineering are not included in this notification. 
Clause 2 - Novel food shall be evaluated on safety assessment prior to submit its label to 
Food and Drug Administration for approval before use.  
Clause 3 - To evaluate safety assessment of such novel food, results of safety 
assessment by risk assessment centres recognized by Food and Drug Administration 
together with other relevant information described in the annex of this notification shall be submitted to Food and Drug Administration. 
Information and scientific data about novel food required in Annex covers general 
information, specification, history of use, production process, analytical method, 
recommended dose or instruction for use, toxicological information consisting of absorption, distribution, metabolism, and elimination (ADME) and toxicological studies in 
animal and/or human, and nutrition information. G/SPS/N/THA/235 
 
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  Clause 4 - Novel food shall have specification and condition of use as approved by Food 
and Drug Administration. 
Clause 5 - Producers or Importers of novel food shall follow this notification, a particular 
notification and relevant regulations with such novel foods. 
Clause 6 - Labeling of novel food shall comply  with the notification of MOPH (No. 367) 
B.E. 2557 (2014) Re: Labeling of Prepackaged Foods, except clause 4(9) shall display 
date, month, and year of production and date, month, and year of expiration for 
consumption by expressing date, month, year respectively, and shall incorporated with declarations of "Produce", "Expire", or "Consume before", as the case may be. In 
addition, the following information shall be expressed on its label: 
1) Name of active ingredient (if any); and  
2) Instruction of use, or condition of use such as type or category of food and 
maximum permitted level of use. 
Clause 7 - This notification does not apply to novel food for exportation. 
Clause 8 - This notification does not apply to producers or importers of novel foods 
which are permitted and produced or imported pr ior to the date of this notification come 
into force. 
Clause 9 - This notification shall come into force as from the day following date of its 
publication in the Government Gazette. 
7. Objective and rationale: [X] food safety, [ ] animal health, [ ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [ ] protect territory from 
other damage from pests.   
8. Is there a relevant international st andard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g. title or serial  n u m b e r  o f  C o d e x  
standard or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[X] None Does this proposed regulation conform to the relevant international standard?   
[ ] Yes   [ ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language (s) in which these are available: 
Notification of the Ministry of Public He alth No. 367 B.E. 2557 (2014) entitled: Labeling 
of Prepackaged Foods (available in Thai and English) 
10. Proposed date of adoption (dd/mm/yy) : To be determined. 
Proposed date of publication (dd/mm/yy) : To be determined. 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : On the date after being notified in the Official Gazette. 
[ ] Trade facilitating measure   G/SPS/N/THA/235 
 
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  12. Final date for comments: [X] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 4 April 2016 
Agency or authority designated to hand le comments: [X] National Notification 
Authority, [X] National Enquiry Point. Address, fax number and e-mail address 
(if available) of other body:  
E-mail: spsthailand@gmail.com 
13. Text(s) available from: [X] National Notifi cation Authority, [X] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
E-mail: spsthailand@gmail.com