Taiwan FDA considers use of 2’-FL fermented from new GM source for infant medical foods

The two strains of interest are GM Escherichia coli ​K-12 DH1 MDO MAP1001d and Escherichia coli ​BL21 (DE3) #1540, which are also the only two strains that are approved to ferment 2’-FL in Taiwan at present.

At the moment, 2’-FL fermented using these two strains cannot be used in FSMPs for infants.

However, it could be used in infant formula foods, complementary foods for toddlers, and dairy powder or related products specially designed for children below seven years old.

The Taiwan FDA announced a public consultation​ to consider the use of 2’-FL fermented via these two strains in all infant and toddler food on September 20.

The intention is to “effectively and reasonably regulate [the use of] non-traditional food ingredients, while considering special nutrition needs at the same time,” ​the regulator said.

It added that the safety of 2’-FL fermented from these GM sources have been considered, in particular, the bacteria is considered non-pathogenic and is unlikely to survive in host tissues or to cause disease.

The public consultation, which starts from September 21, will end in 60 days.

Use of 2’-FL ​

The development in Taiwan follows a string of updates regarding 2’-FL from China and New Zealand earlier this year.

The ingredient 2’-FL is the most abundant oligosaccharides in human breast milk and is often used as a prebiotic or human milk oligosaccharide (HMO) in infant formula milk.

In May, we reported how China’s National Center for Food Safety Risk Assessment (CFSA)​ is gathering public feedback on the use of 2’-FL in infant formula and foods for toddlers and young children.

In January, we reported Food Standard Australia New Zealand (FSANZ)​ on its plans to use 2’-FL fermented using the GM strain E. coli​ BL21 in infant formula. It has also conducted a public consultation on this issue.

Prior to that, the FSANZ has allowed the use of 2’-FL fermented from GM E. coli ​K12 SCR6 in infant formula and supplementary foods for young children since December 2019.

In terms of industry updates, Danish firm Chr. Hansen has recently been approved to supply HMOs to new markets, including Israel.

The firm has ramped up its HMO development after acquiring Jennewein Biotechnologie in 2020.