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  
MOHW Food No.1111303588, 7 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 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 the 
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 spray 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 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 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 displayed 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”. Final 
products containing 2ʹ-FL as one of its ingredients are exempted from 
this labeling requirement. 
  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-glucopyranose  
Chemical formula: C 18H32O15 
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 reaction, 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. 