The two genetically modified strains are Escherichia coli (E. coli) BL21 (DE3) #1540 and E. coli K-12 DH1 MDO MAP1001d. These are also the only two strains currently approved by Taiwan’s authorities to ferment 2’-FL.
Taiwan’s Ministry of Health and Welfare made the announcement on February 7, adding that the regulation is effective from that day.
Previously, 2’-FL fermented from these two strains can only be used in infant formula foods, complementary foods for toddlers, and dairy powder for children below seven years old.
The ministry said the move was to more effectively regulate non-traditional food raw material and to meet special nutrition needs.
“Considering the Act Governing Food Safety and Sanitation and the detailed regulations, special nutrition foods that come under ‘infant and follow-up formula foods’ would include infant formula foods, follow-up infant formula and infant formula for special medical purposes.
“[As such], the Ministry of Health and Welfare, having assessed the relevant safety standards, is allowing infant formula for special medical purposes to use the aforementioned 2’-FL as food raw materials…,” said the notice.
This development comes after the Taiwan Food and Drug Administration (FDA) conducted a public consultation on the matter last September.
Third GM-modified strain
In addition, the ministry is considering the use of 2’-FL fermented from another genetically modified E.coli strain in infant and follow-up formula, as well as dairy powder products for kids below seven years old.
The strain in question is the genetically modified E.coli K-12 MG1655 INB000846.
The ministry has since drafted the limitations and regulations for use, which is open for public consultation for 60 days from February 10.
The ministry noted that 2’-FL fermented from this strain, after going through a series of purification process, will not contain genetically modified microorganisms or its transgenes.
The dosage limit has been proposed at 1.2 g/l, similar to that of 2’-FL fermented by the two aforementioned strains.
Taiwan first allowed the use of 2’-FL in infant, follow-up and young children formula products two years ago.
The oligosaccharide is one of the most common ingredients in infant formula products and has been approved for use in several APAC markets, such as New Zealand and Australia.
However, it is pending approval in the most lucrative infant formula market in the region -r China. So far, 2’-FL and Lacto-N-neotetraose (LNnT) fermented using E. coli have passed the technical review of China National Center for Food Safety Assessment (CFSA)