G/SPS/N/TPKM/596  
 
20 September 2022  
(22-7074) 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 ingredients to be used in food  
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 Amendment for "The Use Restrictions and Labeling 
Requirements of 2' -fucosyllactose Produced by Genetically Modified Escherichia  coli strain  
BL21 (DE3) #1540 as a Food Ingredient" and "The Use Restrictions and Labeling 
Requirements of 2' -fucosyllactose Produced by Genetically Modified Escherichia coli  strain 
K-12 DH1 MDO MAP1001d as a Food Ingredient" . Language(s):  English . Number of 
pages:  6 
https://members.wto.org/crnattachments/2022/SPS/TPKM/22_6408_00_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/TPKM/22_6408_01_e.pdf  
6. Description of content:  "The Use Restrictions and Labeling Requirement of 
2'-fucosylla ctose Produced by Genetically Modified Escherichia coli strain  BL21 (DE3) 
#1540 as a Food Ingredient" and "The Use Restriction and Labeling Requirement of 
2'-fucosyllactose Produced by Genetically Modified Escherichia coli  strain K -12 DH1 MDO 
MAP1001d as a  Food Ingredient" were promulgated and came into effect on 16 December 
2020 and 16 June 2021, respectively. 2' -fucosyllactose referred to above regulations can 
be used for infant formula, follow -up infant formula and milk powder or similar products 
for chi ldren under seven years old.  
In accordance with the provisions of subparagraph 2 of Article 3 of the Act Governing Food 
Safety and Sanitation and Article 2 of the Enforcement Rules of the Act Governing Food 
Safety and Sanitation, the term "infant and follo w-up formula" prescribed in the Act shall 
include infant formula, follow -up infant formula and infant formula for special medical 
purposes.  
Therefore,  this draft amendment specifies to extend "infant formula for special medical 
purposes" to the usage scope , other use restrictions and labeling requirements have not 
changed.  
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 p ests.   G/SPS/N/T PKM/596  
 
- 2 - 
 
  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 st andard?  
[ ] 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:    
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) : 19 November 2022  
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