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Regulation for The Use Restriction and Labeling Requirement of 2′-fucosyllactose Produced by Genetically Modified Escherichia coli strain K-12 DH1 MDO MAP1001d as a Food Ingredient2021/06/16

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Regulation for The Use Restriction and Labeling Requirement of 2′-fucosyllactose Produced by Genetically Modified Escherichia coli strain K-12 DH1 MDO MAP1001d as a Food Ingredient

MOHW Food No.1101301211, 16 June 2021

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 K-12 DH1 MDO MAP1001d (hereinafter referred to as “E. coli K-12 MAP1001d”). The 2′-FL powder can be purified from the fermentation broth via a sequence of purification steps including ion removal, activated charcoal treatment, filtration, concentration, crystallization with acetic acid, solid-liquid separation, washing and drying etc. The final 2′-FL 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 K-12 MAP1001d 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 K-12 MAP1001d 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”.