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Taiwan to Remove the Use Restrictions of 2′-FL on Infant Formula for Special Medical Purposes

TFDA proposes to amend the usage scale of 2′-FL produced by E. coli K-12 MAP1001d or E. coli BL21 (DE3) #1540 to cover infant formula for special medical purposes.

On September 20, 2022, Taiwan Food and Drug Administration (TFDA) consulted on the amendment to the use restriction of 2′-fucosyllactose (2′-FL) produced by genetically modified Escherichia coli strain K-12 DH1 MDO MAP1001d (hereinafter referred to as “E. coli K-12 MAP1001d”) and genetically modified Escherichia coli strain BL21 (DE3) #1540 (hereinafter referred to as “E. coli BL21 (DE3) #1540”). Any comments on the drafts shall be returned within 60 days since September 20, 2022.

The authority plans to expand the usage scale of 2′-FL to cover infant formula for special medical purposes. The current regulation on E. coli K-12 MAP1001d and the regulation on E. coli BL21 (DE3) #1540 both specify that 2′-FL produced by either strain “can only be used for infant formula, follow-up infant formula and milk powder or similar products for children under 7 years old.” The usage scale does not include “infant formula for special medical purposes”.

In addition, the two drafts modify “infant formula, follow-up infant formula” to “infant and follow-up formula”. As prescribed in Enforcement Rules of the Act Governing Food Safety and Sanitation, the term “infant and follow-up formula” shall include infant formula, follow-up infant formula and infant formula for special medical purposes. The new drafts thus remove the use restrictions of 2′-FL fermented from E. coli K-12 MAP1001d or E. coli BL21 (DE3) #1540 on infant formula for special medical purposes.

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