DSM leads the way as HMO access in China reaches a pivotal milestone

By:  Talking Nutrition Editors

  • The regulatory pathway to HMO innovation opens as China confirms the safety of six different manufacturing strains to produce HMOs, a critical milestone in the journey to providing products with these novel ingredients in China.
  • The close collaboration of DSM’s global and local regulatory teams led to an effective strategy for navigating the HMO approval process in China. The teams’ vision and determination has allowed DSM to lead the way to significant innovation in China.
  • As a leader in Early Life Nutrition, DSM has already passed significant steps in China’s comprehensive process for HMO approval, demonstrating its commitment to advancing the availability of HMO products in the Chinese market.

The ability to offer HMOs in Chinese products will become a reality

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

DSM’s vision for HMO innovation in China helps lead the way to advanced nutrition solutions

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.

The relevance and importance of HMOs

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 internal expertise – crucial to the new process

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.

A sizeable opportunity to advance infant health

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.

DSM: A Leader in Innovative Solutions for Early Life Nutrition

DSM is a reliable, end-to-end, innovative, purpose-led partner powered by expert services to deliver science-backed nutrition and health products and quality customized solutions.

Partner with DSM for access to our broad portfolio of science-backed products, customized solutions, and expert services aimed at reliably supporting your entire product life cycle, from concept to consumer. Visit www.partnerwithdsm.com to get started.

Published on

25 October 2021

Tags

  • Essentials for early life
  • HMOs
  • Industry News
  • Article
  • Procurement
  • Senior Management

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References

  1. Bode  L. Human milk oligosaccharides: every baby needs a sugar mama. Glycobiology. 2012a;22(9):1147-1162.
  2. Thurl S, Munzert M, Boehm G, Matthews C, Stahl B. Systematic review of the concentrations of oligosaccharides in human milk. Nutr Rev. 2017;75(11):920-933.
  3. Ninonuevo MR, Park Y, Yin H, et al. A strategy for annotating the human milk glycome. J Agric Food Chem. 2006;54(20):7471-7480.
  4. Austin S, De Castro CA, Bénet T, et al. Temporal Change of the Content of 10 Oligosaccharides in the Milk of Chinese Urban Mothers. Nutrients. 2016;8(6).
  5. Soyyılmaz B, Mikš MH, Röhrig CH, Matwiejuk M, Meszaros-Matwiejuk A, Vigsnæs LK. The Mean of Milk: A Review of Human Milk Oligosaccharide Concentrations throughout Lactation. Nutrients. 2021;13(8).
  6. Berger B, Porta N, Foata F, et al. Linking Human Milk Oligosaccharides, Infant Fecal Community Types, and Later Risk To Require Antibiotics. mBio. 2020;11(2).
  7. Puccio G, Alliet P, Cajozzo C, et al. Effects of Infant Formula With Human Milk Oligosaccharides on Growth and Morbidity: A Randomized Multicenter Trial. J Pediatr Gastroenterol Nutr. 2017;64(4):624-631.
  8. Kunz C. Historical aspects of human milk oligosaccharides. Adv Nutr. 2012;3(3):430s-439s.
  9. Asakuma S, Hatakeyama E, Urashima T, et al. Physiology of consumption of human milk oligosaccharides by infant gut-associated bifidobacteria. J Biol Chem. 2011;286(40):34583-34592.
  10. Goehring KC, Marriage BJ, Oliver JS, Wilder JA, Barrett EG, Buck RH. Similar to Those Who Are Breastfed, Infants Fed a Formula Containing 2'-Fucosyllactose Have Lower Inflammatory Cytokines in a Randomized Controlled Trial. J Nutr. 2016;146(12):2559-2566.
  11. Smilowitz JT, Lebrilla CB, Mills DA, German JB, Freeman SL. Breast milk oligosaccharides: structure-function relationships in the neonate. Annu Rev Nutr. 2014;34:143-169.
  12. Yu ZT, Chen C, Newburg DS. Utilization of major fucosylated and sialylated human milk oligosaccharides by isolated human gut microbes. Glycobiology. 2013;23(11):1281-1292.
  13. Triantis V, Bode L, van Neerven RJJ. Immunological Effects of Human Milk Oligosaccharides. Front Pediatr. 2018;6:190.
  14. Weichert S, Jennewein S, Hüfner E, et al. Bioengineered 2'-fucosyllactose and 3-fucosyllactose inhibit the adhesion of Pseudomonas aeruginosa and enteric pathogens to human intestinal and respiratory cell lines. Nutr Res. 2013;33(10):831-838.
  15. Coppa GV, Zampini L, Galeazzi T, et al. Human milk oligosaccharides inhibit the adhesion to Caco-2 cells of diarrheal pathogens: Escherichia coli, Vibrio cholerae, and Salmonella fyris. Pediatr Res. 2006;59(3):377-382.
  16. Morrow AL, Ruiz-Palacios GM, Jiang X, Newburg DS. Human-milk glycans that inhibit pathogen binding protect breast-feeding infants against infectious diarrhea. J Nutr. 2005;135(5):1304-1307.
  17. Yu ZT, Nanthakumar NN, Newburg DS. The Human Milk Oligosaccharide 2'-Fucosyllactose Quenches Campylobacter jejuni-Induced Inflammation in Human Epithelial Cells HEp-2 and HT-29 and in Mouse Intestinal Mucosa. J Nutr. 2016;146(10):1980-1990.
  18. Lin AE, Autran CA, Szyszka A, et al. Human milk oligosaccharides inhibit growth of group B Streptococcus. J Biol Chem. 2017;292(27):11243-11249.
  19. China’s local infant formula brands rise to compete in an international arena. Global Times. Published 12 May 2021. Accessed 7 July 2021. https://www.globaltimes.cn/page/202105/1223271.shtml.
  20. China Infant Formula Market 2021-2025 - Gaining Popularity by Goat Milk Instant Formula/Favorable Policies for Domestic Brands/Growing Opportunity for Liquid Infant Formula. Global Newswire. Published 12 May 2021. Accessed 7 July 2021. https://www.globenewswire.com/en/news-release/2021/05/12/2228020/28124/en/China-Infant-Formula-Market-2021-2025-Gaining-Popularity-by-Goat-Milk-Instant-Formula-Favorable-Policies-for-Domestic-Brands-Growing-Opportunity-for-Liquid-Infant-Formula.html.
  21. Global $275+ Million Human Milk Oligosaccharides (HMO) Market to 2026. Global Newswire. Published 7 January 2021. Accessed 7 July 2021. https://www.globenewswire.com/en/news-release/2021/01/07/2154689/28124/en/Global-275-Million-Human-Milk-Oligosaccharides-HMO-Markets-to-2026.html.

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