The strain permitted is GM E. coli K-12 MG1655 INB000846, effective from June 1, the FDA announced.
The 2’-FL fermented from this particular strain could be used in infant and follow-up formulas, complementary foods for toddlers, Foods for Special Medical Purposes (FSMP), and milk powder for kids below seven years old.
The maximum permitted usage is 1.2 gram per litre.
In terms of purity, the fermented output should be made up of more than 94 per cent of 2’-FL, while D-Lactose and 2’-Fucosyl-D-lactulose should be below three per cent and 1.5 per cent respectively.
Both L-Fucose, Difucosyllactose should be below two per cent and the sum of 2’-FL, D-lactose, L-Fucose, Difucosyllactose should be above 96 per cent.
Violators will face a penalty of between 30k and 3 million NTD.
The development comes after the regulator requested for public feedback on the matter in February.
Prior to this, the Taiwan FDA has permitted the use of GM E. coli BL21 (DE3) #1540 strain and GM E.coli K-12 DH1 MDO MAP1001d strain to ferment 2’-FL.
Taiwan first approved the use of 2’-FL in nutrition products for infants and kids two years ago.
Stating the source
On the other hand, companies are using 2’-FL produced from the GM strains are required to state so on the product label, unless the products have undergone further processing.
For example, they are supposed to state that “the 2’-FL is produced by GM microorganisms” (本品為利用基因改造微生物生產) or “the 2’-FL is produced by GM microorganisms, but the final product does not contain GM microorganisms and its transgene” (本品為利用基因 改造微生物生產，但最終不含基因改造微生物及其轉殖基因).
2’-FL market potential
While 2’-FL has been approved for use in infant formulas across various APAC countries, including Singapore, New Zealand, and Australia, 2’-FL, along with other HMOs, are not yet approved in mainland China.
The Chinese authorities have conducted yet another round of public consultation in February on the use of 2’-FL as a food additive.
According to Kirin, China is expected to take up half of the total HMO market share for powdered milk. Based on the regulatory development, it is hoping to see an uptake from China from next year.
