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

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 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 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”.