G/SPS/N/TPKM/602  
 
9 February 2023  
(23-0960) 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):  Infant and follow -up formula (including infant formula, follow -up 
infant formula and infant formula for  special medical purposes), and milk powder or similar 
products for children under seven years old  
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 for The Use Restrictions and Labeling 
Requirements of 2′ -fucosyllactose Produced by Genetically Modified  Escherichia coli  
strain  K-12 MG1655 INB000846 as a Food Ingredient . Language(s):  Chinese and English . 
Number of pages:  5 in total  
https://members.wto.org/crnattachments/2023/SPS/TPKM/23_1010_00_x.pdf  
https://members.wto.org/crnattachments/2023/SPS/TPKM/23_1010_00_e.pdf  
6. Description of content:  This draft regulation specifies the use restrictions and label ing 
requirements for the 2' -fucosyllactose produced by genetically modified Escherichia coli  
strain K -12 MG1655 INB000846 for food purposes.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from anim al/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/602  
 
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  9. Other relevant documents and language(s) in which these are available:  
The Draft for The Use Restrictions and Labeling Requirements of 2′ -fucosyllactose 
Produced by Genetically Modified  Escherichia coli  strain K -12 MG1655 INB000846 as a 
Food Ingredient (MOHW Food No. 1111303853, 9 February 2023) is available in English 
from the Nationa l Notification Authority, National Enquiry Point, and Ministry of Health and 
Welfare. The regulation will be published in the Official Government Gazette when 
adopted. The full text may be downloaded from the following website: 
http://www.fda.gov.tw/TC/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) : 10 April 2023  
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: +(886 2) 2787 8000 ext. 7318  
Fax: +(886 2) 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: +(886 2) 2787 8000 ext. 7318  
Fax: +(886 2) 2653 1062  
E-mail: yoannaluo@fda.gov.tw