China authority seeks public consultation on use of HMO 2’-FL in infant formula

By Tingmin Koe contact

- Last updated on GMT

Human milk oligosaccharide (HMO) 2’-fucosyllactose (2’-FL) is an increasingly common ingredient in infant formula. ©Getty Images
Human milk oligosaccharide (HMO) 2’-fucosyllactose (2’-FL) is an increasingly common ingredient in infant formula. ©Getty Images

Related tags: HMOs, 2'-fucosyllactose, Infant formula

China’s food regulator is seeking public consultation on the use of the human milk oligosaccharide (HMO) 2’-fucosyllactose (2’-FL) in infant formula as well as in foods for toddlers and young children.

The National Center for Food Safety Risk Assessment (CFSA) made the announcement​ in April, which is now open for public consultation by May 13.

In its announcement, 2’-FL is categorised as a novel type of fortifier for use in dairy powder for children, foods for infants, toddlers, and young children, as well as foods for special medical use (FSMP) for infants. 

The dosage permitted is within 0.7g/L and 2.4g/L.

If permitted, this will be a breakthrough in the industry, because 2’-FL is not yet permitted for use in China. Products containing 2’-FL are entering the country by cross-border e-commerce.

This is not the first time that the Chinese authorities are deliberating on the use of 2’-FL.

In August 2016, there was an application to the Chinese authorities to approve a 2’-FL ingredient derived from microorganisms as a fortifier in infant and toddler foods.

In the same month, CFSA commenced a public consultation on that particular application but no update was given.

Last July, China’s National Health Commission (NHC) once again started assessing applications that called for 2’-FL’s use as a food fortifier.  

The NHC has been assessing three applications as of last November.  

Elsewhere, 2’-FL has been permitted for use in infant and toddler foods by the USFDA, European Commission, Food Standards Australia New Zealand (FSANZ), and Taiwan FDA.

The HMO can be produced via microbial fermentation using different bacteria strains.

For the FSANZ, it has previously approved 2’-FL produced via microbial fermentation using the genetically-modified Escherichia ​coli (E. coli) K12 production strain SCR6.

In January, we reported that​ the FSANZ is seeking public comment on the use of 2’-FL produced via microbial fermentation using E. coli BL21 strains.

Aside from 2’-FL, there are other HMOs such as 3’-fucosyllactose (3’FL), 3’-sialyllactose (3’SL), 6’-sialyllactose (6’SL), and lacto-N-neotetraose (LNnT). Some of which are used in infant formulas.

One example is Beba Supreme Pre, an infant liquid milk product by Nestle that was introduced to the China market during the China International Import Expo (CIIE).

The product contains five types of HMOs, including 2’FL/DFL mix, LNnT, lacto-N-tetraose (LNT), 3’SL, and 6’SL.

The third most abundant solid component in human milk, HMOs have garnered increasing attention from the industry, with some such as H&H Group studying its health benefits when paired with certain probiotic strains – a new category which the company termed as “HMObiotics​”.

Related topics: Markets, Regulation

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