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.1121300951, 1 June 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.