[Updated] Taiwan Removes the Use Restrictions of 2′-FL on Infant Formula for Special Medical Purposes

Updated:

On February 7, 2023, Taiwan officially promulgated the amendment with immediate effect, as the authority finished the safety assessment of including infant formula for special medical purposes in the usage scale. The amendment was circulated by the WTO the same day.

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.