Draft for The Use Restrictions and Labeling 
Requirements of 2ʹ-fucosyllactose Produced by 
Genetically Modified  Escherichia coli  strain K-12 
MG1655 INB000846 as a Food Ingredient 
MOHW Food No.1111303853, 9 February 2023 
Article 1 
The regulation is prescribed in accordance with the provisions of Paragraph 2 
of Article 15-1 and Subparagraph 10 of Paragraph 1 of Article 22 of the Act 
Governing Food Safety and Sanitation. 
 
Article 2 
The 2ʹ-fucosyllactose (2ʹ-FL) referred to herein is produced by fermentation 
process using genetically modified Escherichia coli  strain K-12 MG1655 
INB000846. The 2ʹ-FL powder can be purified from the fermentation broth via 
a sequence of purification steps including filtration, removing the antifoaming 
agents, electrodialysis, ion exchange chromatography, activated charcoal 
treatment, evaporation, crystallization, and spray drying etc. The final 2ʹ-FL 
powder shall not contain any genetically modified microorganism and its 
transgenes. 
 
Article 3 
For use as a food ingredient, the 2ʹ-FL produced by  E. coli K-12 MG1655 
INB000846 shall comply with the following requirements: 
1. Specifications listed in the Appendix. 
2. Can only be used for infant and follow-up formula, and milk powder or 
similar products for children under 7 years old. 
3. The maximum level of 2ʹ-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 2ʹ-FL produced by  E. coli K-12 
MG1655 INB000846 shall be displayed one of the following information: 
“The 2ʹ-fucosyllactose is produced by genetically modified 
microorganism” or “The 2ʹ-fucosyllactose is produced by genetically 
modified microorganism, but ultimately does not contain any genetically 
modified microorganism and its transgenes”. Final products containing 2ʹ-
FL as one of its ingredients are exempted from this labeling requirement. 
  Appendix 
Specifications of the 2ʹ-fucosyllactose produced by genetically modified  Escherichia coli  
strain K-12 MG1655 INB000846 
Chemical name: α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranose 
Chemical formula: C 18H32O15 
Molecular weight: 488.44 g/mol 
CAS No: 41263-94-9 
Physical parameter: 2ʹ-fucosyllactose is a white to off white powder 
Purity  
2ʹ-fucosyllactose: ≥ 94% 
D-Lactose: ≤ 3.0% 
L-Fucose: ≤ 2.0% 
Difucosyllactose: ≤ 2.0% 
2ʹ-Fucosyl-D-lactulose: ≤ 1.5% 
Sum of 2ʹ-fucosyllactose, D-lactose, L- fucose and 
Difucosyllactose: ≥ 96% 
Genetically modified microorganisms detection: Negative (Detected by real-time quantitative polymerase 
chain reaction, qPCR) 
Water: ≤ 9.0% 
Total ash: ≤ 0.5% 
Residual proteins: ≤ 0.01% 
Heavy Metals  
Lead: ≤ 0.05 mg/kg 
Arsenic: ≤ 0.2 mg/kg 
  
 