Taiwan Permits the Use of 2′-Fucosyllactose in Infant Formula and Children’s Milk Powder

On June 16, 2021, Taiwan FDA¹ approved the use of 2’-fucosyllactose (2’-FL), produced by genetically modified Escherichia coli strain K-12 DH1 MDO MAP1001d, as a novel food ingredient in infant formula, follow-up infant formula, and milk powder or similar products for children under 7 years old. 

What is 2’-FL and its production process

2′-FL is an oligosaccharide, composed of L -fucose, D -galactose and D -glucose units. It is the most prevalent human milk oligosaccharide (HMO) naturally present in human breast milk, accounting for about 30% of all of HMOs.² Emerging scientific evidence shows that 2’-FL supports the development and maintenance of a healthy gut microbiome and immune system beyond infant nutrition.³ 

According to the Taiwan authority, the approved 2′-FL in this notice is produced by fermentation using genetically modified Escherichia coli strain K-12 DH1 MDO MAP1001d. The 2′-FL powder can be purified from the fermentation supernate via a series of purification steps including ion-exchange resin, etc. The final 2′-FL powder shall not contain any genetically modified microorganism and its transgenes.

Use and labeling requirements

As revealed by the notice, the maximum use limit of 2′-FL in infant formula (for infants under 6 months old), follow-up infant formula (for infants of 6-12 months old) and milk powder or similar products for children under 7 years old is 1.2 g/L, calculated in the final product ready for use or reconstituted.

For products added with such an ingredient, it should label following message “The 2′-FL is produced by genetically modified microorganism” or “The 2′-FL is produced by genetically modified microorganism, but ultimately does not contain any genetically modified microorganism and its transgenes”.

Specification of 2′-FL is also detailed in this notice.