G/SPS/N/TPKM/540  
 
23 July 2020  
(20-5049) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member:  THE SEPARATE CUSTOMS  TERRITORY OF TAIWAN , PENGHU, 
KINMEN AND MATSU  
If applicable, name of local government involved:   
2. Agency responsible:  Ministry of Health and Welfare  
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):  Food ingredient to be used in food  
4. Regions or countries likely to be affected, to the extent releva nt or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft Regulation for The Use Restrictions and Labeling 
Requirement of 2' -fucosyllactose Produced by Genetically Modified  Escherichia coli  strain 
BL21 (DE3) #1540 as a Food Ingredient . Language(s):  Chinese and English . 
Number  of pages:  5 
https://members.wto.org/crnattachments/2020/SPS/TPKM/20_4411_00_e.pdf  
https://members.wto.org/crnattachments/2020/SPS/TPKM/20_4411_00_x.pdf  
6. Description of content:  This draft regulation specifies the use restrictions and labeling 
requirement for the 2' -fucosyllactose produced by genetically modified Escherichia c oli 
strain BL21 (DE3) #1540 for food purposes.  
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:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
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:   G/SPS/N/TPKM /540 
 
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  9. Other relevant documents and language(s) in which these are available:  
The Draft Regulation for The Use Restrictions and Labeling Requirement of 
2'-fucosyllactose Produced by Genetically Modified  Escherichia c oli strain BL21 (DE3) 
#1540 as a Food Ingredient (MOHW Food No.1091301423,  22 July 2020) is available in 
English from the National Notification Authority, National Enquiry Point, and Ministry of 
Health and Welfare. The regulation will be published in the O fficial Government Gazette 
when adopted. The full text may be downloaded from the following website: 
http://www.fda.gov.tw/eng/index.aspx  (available in Chinese)   
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) : To be determined.  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 21 September 2020  
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:   
Food and Drug Administration  
Ministry of Health and Welfare  
No.161 -2, Kunyang St, Nangang District, Taipei City 115 -61, Taiwan  
Tel: +(8862) 2787 8000 ext 7318  
Fax: +(8862) 2653 1062  
E-mail: yoannaluo@fda.gov.tw   
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:   
Food and Drug Administration  
Ministry of Health and Welfare  
No.161 -2, Kunyang St, Nangang District, Taipei City 115 -61, Taiwan  
Tel: +(8862) 2787 8000 ext 7318  
Fax: +(8862) 2653 1062  
E-mail: yoannaluo@fda.gov.tw