By: Talking Nutrition Editors
The Chinese Ministry of Agriculture and Rural Affairs, MARA has confirmed the safety of six different manufacturing strains to produce HMOs, opening the door to the next steps in the regulatory process of bringing products with HMO innovation to the Chinese market. This noteworthy achievement is due to DSM’s steadfast commitment to purposeful advancements in Early Life Nutrition (ELN) in China.
The strain safety approval is the first step of a new and thorough procedure for reviewing and authorizing the use of HMOs in infant formula products in China, which 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. With the achievement of having obtained the safety clearance of the manufacturing strains, the next step will be to seek approval of individual HMO ingredients
In line with DSM’s commitment to creating brighter lives for all, the company filed several dossiers for safety clearance of the manufacturing strains used to produce its HMOs: 2’FL, LNnT, DFL, LNT, 3’SL, and 6’SL. This early and swift action illustrates DSM’s promise to bring meaningful solutions to the Early Life Nutrition market.
Reinforcing this point, James Young, VP of HMO Innovation and Business Development at DSM tells us: “As a leader in the ELN space, DSM has pledged to provide the best in infant nutrition for all. We will forge ahead – guided by our bright science and researchers – to deliver positive transformations to as many people as possible. We continue our focus on China and ensure that the benefits of HMOs are available, through balanced infant formulas, to provide the best nutrition for all babies.”
With the upcoming opportunity to offer products with HMOs in China, DSM supports its customers in developing science-backed solutions to help set formula-fed infants on a path to a long, healthy life. This is in accordance with DSM’s promise to support the first 1,000 days and help keep the world’s growing population healthy.
HMOs are complex carbohydrates and the third largest solid component of human milk.1,2 Their significant contribution to the composition of human milk signals an important role in early development. Over 200 HMOs have been identified in human milk so far,3 and to date, researchers have been able to quantify roughly 20 to 30 individual HMOs.2,4
Yet, an even smaller number of HMOs represent the majority of HMO content in human milk: a recent review shows that around 15 HMOs contribute over 75% of the total amount of these oligosaccharides in human milk.5 The six manufacturing strains recently confirmed to be safe by the Chinese government enable the production of a highly significant proportion of HMOs in breastmilk by biomass and cover the 3 main structural classes of HMOs.
HMOs have been shown to positively influence infant health.1,6,7 Once ingested, HMOs largely resist digestion and reach the intestines intact.1,8 There, they serve as prebiotics, selectively supporting the growth of beneficial bacteria in the GI tract and creating a community of healthy microbes in the gut.6,9 Researchers are identifying additional mechanisms by which HMOs may impact health. Some preclinical and clinical data suggest the potential for HMOs to positively impact gut barrier function and help maintain a healthy immune system.10-13 Emerging data also suggest HMOs may deflect the adhesion of undesirable organisms to cell walls by mimicking cell surface receptors.14-18
DSM’s Regulatory Affairs group played a central and essential role in the company’s filing of the HMO manufacturing strain safety dossiers. The seasoned team’s experience allowed them to effectively navigate the diligent process, working to prepare submission materials in parallel to the new procedure being established by the Chinese government. Liaising with external regulatory and scientific experts in China allowed DSM reaching the vital milestone of submitting multiple regulatory dossiers as early as possible after the procedure was opened.
The new procedure is thorough, as an extensive safety and suitability assessment is critical for new ingredients that may be added to infant formula. It includes a strain risk assessment by the Ministry of Agriculture and Rural Affairs (MARA), then a five-phase evaluation of the HMO ingredient by the Centre for Food Safety Risk Assessment (CFSA), a subdivision of the National Health Commission (NHC). The expected timeline, from the filing of the manufacturing strain safety dossiers to final approval of the HMO ingredients, is estimated to take approximately 18 to 30 months.
The scale of China’s infant formula market is approximately $30 billion and accounts for roughly 50% of the global market.19 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 the middle class and dual income families].20 Similarly, opportunities for HMOs are expected 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.21 In response to the growing need for the highest-quality nutrition products in the Chinese market, DSM responded by quickly engaging with the process established by the Chinese government to bring HMOs to the market.
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25 October 2021
6 min read
Customized blends of desired functional ingredients in one single, efficient, homogenous premix.