G/TBT/N/THA/523  
 
31 October 2018  
(18-6841) Page: 1/3 
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 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:   
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 applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable): Enzymes 
for Food Processing or Food enzymes  
5. Title, number of pages and language(s) of the notified document: Draft MOPH 
Notification, B.E..., entitled "Enzymes for Food Processing" (35 page(s), in Thai)    
6. Description of content: Nowadays, enzymes for food processing are covered by the 
MOPH Notification (No. 281) B.E. 2547 (2004) Re: Food Additives . Enzymes, other than 
those approved by Codex General Standard for Food Additives, have required safety 
evaluations before allowed to use in food production. Due to differences between 
information requirements of enzyme and other chemical food additives, The Ministry of 
Public Health (MOPH) is proposing the notification on Enzymes for Food Processing. This 
notification sets the rulesforindustrial enzymes  intended to be used in food processing 
both as food additives and processing aids. However, the scope of th is notification 
excludes enzymes for nutritional purposes, enzymes produced by traditional microbial 
cultures during fermentation, and enzymes used exclusively in the production of food 
additives or processing aids.  
Enzymes for food processing should be qua lified as follows:  
Enzyme activity is over 85 percent of informed enzyme activity. No genetic engineering 
microbes in 1 g (for enzymes derived from genetic engineering microbes). Quality and 
safety are under the following conditions:  
    3.1 Comply with Codex Advisory Specification for the Identity and Purity of Food 
Additive  
    3.2 Comply with General specification and considerations for enzyme preparations used 
in food processing as follows;  
         - Salmonella spp. : Absent in 25 g sample  
         - Total coliforms: Not more than 30 MPN/g  
          - Escherichia coli : Absent in 25 g sample   
          - Lead: not more than 5 mg/kg  G/TBT/N/THA/523  
 
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            - Antibiotic Activity: Absent in preparations from microbial sources.  
    3.3 Comply with Food and Drug Administr ation (Thailand)’s notifications.  
The draft of notification contains;  
    - List of enzymes for food processing shown in  Annex I .       
   - Information required to approve the usage of new food enzymes provided in  Annex 
II. Food enzymes that are not liste d in Annex I  or not evaluated by JECFA have to undergo 
a comprehensive scientific safety assessment by the risk assessors in Thailand.        
   - Application requirement to demonstrate technological needs and efficiency in  Annex 
III for the usage of food e nzyme that do not fall under the scope of its functional use is 
set out in  Annex I .      
  - List of food additives approved for using in food enzymes and their conditions listed 
in Annex IV .     
  - Enzymes for food processing analytical method is provide d in Annex V  which is 
complied with "Combine compendium of food additive specifications: Analytical methods, 
test procedures and laboratory solutions used by and referenced in the food additive 
specifications".       
  - Labelling requirement for  food enzym e stated in the MOPH Notification Re: Food 
Additives. All food products using enzymes as food additives and processing aids which 
are not included in the list before the enforcement of this notification have to provide 
information for safety assessment and  technological needs within two years from the date 
of entry into force of this notification.     
-This notification shall come into force on the date after being notified in the Royal 
Gazette.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Consumer protection  
8. Relevant documents:   
1. General Specifications and Considerations for Enzyme Preparations used in food 
processing (Joint FAO/WHO Expert Committee on Food Additives)  
2. Principles and Methods for the Risk Assessment of Chemicals in Food (EHC240); 
Chapter 9 Principles related to specific groups of substances (FAO/WHO)   
3. Guideline for the Conduct of Food Safety Assessment of Foods Produced Using 
Recombi nant-DNA Microorganisms (Codex Alimentarius Commission)   
4. Combined compendium of Food Additive specifications vol. 4: Analytical methods, test 
procedures and laboratory solutions used by and referenced in the food additive 
specifications (Joint FAO/WHO E xpert Committee on Food Additives 2006)   
9. Proposed date of adoption: To be determined  
Proposed date of entry into force: To be determined  
10. Final date for comments: 60 days from notification  G/TBT/N/THA/523  
 
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  11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
National Bureau of Agricultural Commodity and Food Standards (ACFS)  
50 Phaholyothin Road, Ladyao,  
Chatuchak, Bangkok 10900,  
Thailand  
Tel: +(662) 561 4024  
Fax: +(662) 561 4034  
E-mail: spsthailand@gmail.com  
Website: http://www.acfs.go.th  
 
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