G/TBT/N/THA/474  
 
1 February 2016  
(16-0673)  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: Food and Drug Administration (Thai FDA) 
Name and address (including telephon e 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 : 
3. Notified under Article 2.9.2 [X], 2.10 .1 [ ], 5.6.2 [ ], 5.7.1 [ ], other: 
4. Products covered (HS or CCCN where applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Novel food 
(ICS: 67.020, 67.040) 
5. Title, number of pages and langua ge(s) of the notified document: Draft Ministry of 
Public Health Notification, No. ... B.E. ... (....) entitled "Novel food" (5 pages, in Thai)  
6. Description of content: The Ministry of Public Health (MOPH) considered that novel 
ingredients which have never been used for consumption as food or used as food 
ingredients as well as novel process that neve r been used earlier for production of food. 
Therefore, the notification of MOPH entitled "N ovel 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) (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) (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) (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 recogn ized 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 G/TBT/N/THA/474 
 
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  absorption, distribution, metabolism, and elimination (ADME) and toxicological studies in 
animal and/or human, and nutrition information. 
 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, ye ar 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 no t 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 prior 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, including the nature of urgent problems where 
applicable: Consumer protection  
8. Relevant documents: Notification of the Ministry of Public Health No. 367 B.E. 2557 
(2014) entitled: Labelling of Prepackaged Foods. 
9. Proposed date of adoption: To be determined 
Proposed date of entry into force: On the date after being notified in the Official Gazette   
10. Final date for comments: 60 days from notification 
11. Texts available from: Nati onal enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
https://member s.wto.org/crnattachments/2 016/TBT/THA/16_0396_00_x.pdf