Regulation  for The Use Restriction  and Labeling 
Requirement  of 2′-fucosyllactose  Produced by Genetically 
Modified  Escherichia coli  strain  BL21 (DE3) #1540  as a 
Food Ingredient  
MOHW Food  No.109130 3448 , 16 December  2020  
Article 1  
The regulation  is prescribed in accordance with the provisions of 
Paragraph 2 of Article 1 5-1 and Subparagraph 10 of Paragraph 1 of 
Article 22 of the Act Governing Food Safety and Sanitation . 
 
Article 2 
The 2 ′-fucosyllactose (2 ′-FL) referred to herein is produced by 
fermentation process using genetically modified Escherichia coli  strain 
BL21 (DE3) #1540 (hereinafter referred to as “E. coli BL21 (DE3) 
#1540”). The 2′-FL liquid concentrate can be purified from th e 
fermentation medium via a sequence of purification steps including 
cation and anion exchange chromatography, concentration , activated 
carbon treatment, filtration, electrodialysis etc . The 2 ′-FL powder is 
derived from the 2 ′-FL liquid concentrate by spra y drying. The final 2 ′-FL 
liquid concentrate and powder shall not contain any genetically modified 
microorganism and its transgenes.  
 
Article 3  
For use as a food ingredient,  the 2′-FL produced by  E. coli BL21 (DE3) 
#1540  shall comply with  the following requirements : 
1. Specifications listed  in the A ppendix . 
2. Can only be used for  infant formula , follow -up infant formula  and 
milk powder or similar products for children under 7 years old . 
3. The maximum level of 2 ′-FL is 1.2 g /L in the final product ready for 
use marketed as such or reconstituted as instructed by the 
manufacturer . 4. The container or external packaging of  2′-FL produced by  E. coli 
BL21 (DE3) #1540  shall be display ed one of the following 
information : “The 2′-fucosyllactose  is produced by  genetically 
modified microorganism ” or “The 2′-fucosyllactose  is produced by 
genetically modified microorganism, but ultimately does not contain 
any genetically modified  microorganism and its transgenes ”. 
  Appendix  
Specifications of the 2′-fucosyllactose  produced by genetically modified  Escherichia 
coli strain  BL21 (DE3) #1540  
Chemical name : α-L-fucopyranosyl -(1→2)-β-D-galactopyranosyl -(1→4)-D-glucopyranos e 
Chemical formula : C18H32O15 
Molecular weight:  488.44 g/mol  
CAS No : 41263 -94-9 
Physical parameter:  2′-fucosyllactose  is a white to off white powder and the liquid concentrate 
aqueous solution is a colourless to slight yellow clear aqueous solution  
Purity   
2′-fucosyllactose : ≧ 90% 
Lactose : ≦ 5.0%  
3-fucosyllactose : ≦ 5.0%  
Difucosyllactose : ≦ 5.0%  
Fucosylgalactose : ≦ 3.0%  
Glucose : ≦ 3.0%  
Galactose : ≦ 3.0%  
Fucose : ≦ 3.0%  
Genetically modified microorganisms  
detection : Negative ( Detected by  real-time 
quantitative  polymerase chain r eaction, qPCR)  
Water : ≦ 9.0% ( powder ) 
Solids content : 45% w/v (± 5% w/v) ( liquid ) 
Sulphated ash : ≦ 0.5%  
Residual proteins : ≦ 0.01%  
Heavy Metals   
Lead : ≦ 0.02 mg/kg  
Arsenic : ≦ 0.2 mg/kg  
Cadmium : ≦ 0.1 mg/kg  
Mercury : ≦ 0.5 mg/kg  
* Specifications listed in this appendix apply to concentrated liquid and powder except for those 
specifically indicated applicable type.  