FDA Taiwan Publishes Regulation for the Use Restriction and Labeling Requirement of 2′-fucosyllactose Produced by Genetically Modified E. coli as Food Ingredient

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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.

To view the document, check out the Food News Monitoring System and stay up-to-date with the latest regulations.

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