G/SPS/N/THA/254  
 
12 November 2018  
(18-7071) 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; ICS numbers should be provided in addition, 
where applicable): Enzymes for food processing or food enzymes  
4. Regions or countries likely to be affe cted, to the extent relevant or practicable : 
[X] All trading partners  
[ ] Specific regions or countries:  
5. Title of the notified document: Draft MOPH Notification, B.E..., entitled "Enzymes for 
Food Processing" . Language(s): Thai. Number of pages: 35 
https://members.wto.org/crnattachments/2018/SPS/THA/18_5683_00_x.pdf  
6. Description of content: Enzymes for food processing are now 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, are required to have safety  
evaluations before they are allowed for use in food production. Due to differences betwe en 
information requirements of enzyme s and other chemical food additives, the Ministry of 
Public Health (MOPH) is proposing the notification on En zymes for Food Processing.  
This notification sets the rules for industrial enzymes intended to be used in food  
processing both as food additives and processing aids. However, the scope of this 
notification excludes : enzymes for nutritional purposes ; enzymes produced by traditional 
microbial cultures during fermentation ; and enzymes used exclusively in the producti on 
of food additives or processing aids.  
Enzymes for food processing should be qualified 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 microb es). 
Quality and safety are unde r the following conditions:  
3.1 Compliance  with Codex Advisory Specification for the Identity and Purity of Food 
Additive  
3.2 Compliance with General specification and considerations for enzyme 
preparations used in food processing  as follows:  
 Salmonella spp. : Absent in 25g sample  
 Total coliforms: Not more than 30MPN/g  
 Escherichia coli : Absent in 25g sample   
 Lead: not more than 5mg/kg  
 Antibiotic Activity: Absent in preparations from microbial sources.  
3.3 Compliance  with Food and Drug Administration (Thailand)'s notifications.  G/SPS/N/THA/254  
 
- 2 - 
 
  The draft notification contains:  
• List of enzymes for food processing shown in Annex I . Food enzymes that are not 
listed in Annex I or not evaluated by JECFA have to undergo a comprehensive scientific  
safety assessment by the risk assessors in Thailand;  
• Information required to approve the usage of new food enzymes provided  in Annex  II;  
• Application requirement to demonstrate technologica l needs and efficiency in 
Annex  III for the usage of food enzyme t hat do not fall under the scope of its 
functional use as set out in Annex I;  
• List of food additives approved for use in food enzymes and their conditions listed in 
Annex IV ; 
• Enzymes for food processing analytical method is provided in Annex V which complie s 
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 enzyme 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: [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 standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or relat ed text) : CAC/RCP 53 -2003 
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  
[X] 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:  
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 
Recombinant -DNA Microorganism s (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 Expert Committee on Food A dditives 2006)   
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 Royal Gazette.  
[ ] Trade facilitating measure  G/SPS/N/THA/254  
 
- 3 - 
 
  12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 30 December 2018  
Agency or authority designated to handle comments: [X ] National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(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  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point.  Address, fax number and e -mail address (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: sp sthailand@gmail.com  
Website: http://www.acfs.go.th