DSM celebrates China’s “pivotal” ruling on HMO manufacturing strains

27 Oct 2021 --- China’s Ministry of Agriculture and Rural Affairs (MARA) has confirmed the safety of six manufacturing strains to produce human milk oligosaccharides (HMOs), thus opening up the regulatory pathway.

DSM, which filed HMO manufacturing strain safety dossiers, is celebrating the move as a “critical milestone” in the journey to providing products – such as infant formula – with these novel ingredients in China.

Godert Zijlstra, global commercial director of HMOs at DSM, tells NutritionInsight that while MARA’s green light is the first step, there are a number of remaining steps to commercializing HMOs in China, which could take up to four years from now. 

“First, there will be a technical review by the China National Center for Food Safety Risk Assessment (CFSA) leading to questions and data requests, known as a gap analysis.”

“Then comes addressing all questions and data requests by the applicant, followed by a public comment period. Then there is the approval of HMOs as ingredients for infant formula by the National Health Commission (NHC),” he explains.

These initial stages are estimated to take 12 to 24 months, depending on the number and nature of data requests. The final step is infant formula registration, which could take 18 to 24 months.  

HMOs are complex carbohydrates and the third-largest solid component of human milk.He adds that other HMO manufacturers can also now apply for regulatory approval in China. 

Forging regulatory pathways
MARA’s verdict follows DSM filing several dossiers for safety clearance of the manufacturing strains used to produce the HMOs 2’FL, LNnT, DFL, LNT, 3’SL and 6’SL.

“Liaising with external regulatory and scientific experts in China allowed DSM to reach the vital milestone of submitting multiple regulatory dossiers as early as possible after the procedure was opened,” states the company. 

According to Zijlstra, there had been no regulatory approval process in China for biotechnology-derived ingredients (manufactured with the help of genetically modified microorganisms as processing aids) until earlier this year.

Therefore, this strain safety approval is part of a new and thorough procedure for reviewing and authorizing the use of HMOs in infant formula products in China. This is followed by the regulatory assessment of the HMO ingredients itself. 

The long-anticipated regulatory process – established in February 2021 – is for food additives to be used as nutritional fortifiers that have been manufactured with the help of genetically modified microorganisms and are highly purified. 

In April, Chr. Hansen also flagged that China’s HMO process had begun, with the company anticipating approvals in the next two years. 

The approval procedure includes MARA’s strain risk assessment, then a five-phase evaluation from CFSA.Targeting a major market
China eventually allowing HMOs will have major ripples across the already lucrative infant nutrition market. DSM says the Chinese infant formula market is valued at approximately US$30 billion and accounts for roughly 50% of the global market. 

The demand for infant formula is expected to grow over the next several years due to the presence of several growth drivers, such as the growing presence of females in the workforce and increases in middle class and dual-income families.

In June, China’s shift toward allowing three children also threw the infant nutrition market into the spotlight. However, industry experts pointed out that growth is currently being driven by value and premiumization rather than volume.  

Additionally, DSM expects opportunities for HMOs to grow considerably over the next five to six years, with market growth estimates forecasting the HMO market to increase by three times its current size at the end of that timeframe. 

HMO expansion
In contrast to China, most other global markets have already approved and launched HMOs. However, Zijlstra flags that there still are other regions cut off from the HMOs. “For example, Korea is one of the markets that continues to not have a regulatory approval process for biotechnology ingredients.”

In addition to regional expansion, HMOs are increasingly being examined for applications beyond infant nutrition, like gut health in adults. 

Over the summer, Adventa Bioscience launched Trulacta, marketed as the first supplement to be made entirely of human milk.

By Katherine Durrell