On June 16, 2021, the Ministry of Health and Welfare Taiwan published a regulation on “The Use Restriction and Labeling Requirement of 2′-fucosyllactose Produced by Genetically Modified E. coli strain K-12 DH1 MDO MAP1001d as Food Ingredient” 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.
The main points in scope on 2′-fucosyllactose (2′-FL) are summarized below:
- It is produced by a fermentation process using genetically modified Escherichia coli strain K12 DH1 MDO 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 etc.
- The final 2′-FL powder shall not contain any genetically modified microorganism and its transgenes.
- 2’-FL for use as Food Ingredient and complies with specifications listed in the Appendix.
- It can only be used for infant formula, follow-up infant formula and milk powder or similar products for children under 7 years old.
- The maximum use 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.
- The container or external packaging of 2′-FL produced by E. coli K12 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 a genetically modified microorganism, but ultimately does not contain any genetically modified microorganism and its transgenes".
The regulation is effective from June 16, 2021.
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