dsm-firmenich achieves regulatory clearance in China for two HMO ingredients for early life nutrition

KAISERAUGST, Switzerland and HEERLEN, Netherlands, Oct. 10, 2023 /PRNewswire/ -- dsm-firmenich, the leading innovator in health, nutrition and beauty, today announced that two of its human milk oligosaccharide (HMO) ingredients have been approved as fortifiers for infant nutrition in China. This approval is a significant milestone as it will create new opportunities for innovation in the field of early life nutrition and make the unique benefits of HMOs accessible to infants and young children in China.

The only two approved HMO ingredients in the Chinese market
The two HMOs that received approval in China include GlyCare™ 2'-fucosyllactose (2'-FL), the most prevalent HMO in human breast milk, and GlyCare™ lacto-N-neotetraose (LNnT), a complex sugar in human milk that is biologically relevant in the early development of the infant gut flora. The 2'-FL HMO has been approved for use in four food categories, including: infant formula, formula for elder infants and young children, infant formula for special medical purposes, and formulated milk powder at a usage level between 0.7-2.4 g/L. LNnT is available for the same applications at 0.2-0.6 g/L.

Data on concentrations of HMOs found in human breast milk globally were taken into consideration by the China National Center for Food Safety Risk Assessment (CFSA) to set the approved maximum usage level. Currently, 2'-FL and LNnT are the only HMO ingredients approved in the Chinese market.

"We are extremely pleased to be able to announce this huge milestone for the China infant formula market and dsm-firmenich," says James Young, Vice-President of Early Life Nutrition at dsm-firmenich. "As the only company with these two HMOs approved for use in China, this approval reaffirms dsm-firmenich's lead position in the global HMO market. HMOs are the next important ingredient for bringing the composition of infant formula closer to breast milk, the gold standard of infant nutrition, and this approval ensures that all infants in China now have access to this important nutrient."

Christoph Röhrig, Head of HNC Glycans & HMO Regulatory Affairs at dsm-firmenich added: "We followed a rigorous regulatory process to ensure all safety and health requirements were met. In the first phase of this process, we achieved safety clearance from the Chinese Ministry of Agriculture and Rural Affairs (MARA) for several of our HMO production strains, including 2'-FL and LNnT. This was followed by the food additive approval process, which comprised a rigorous multiple phase technical assessment by the China National Center for Food Safety Risk Assessment (CFSA), including the opportunity for public comments, that required questions of diverse stakeholders to be addressed. With this breakthrough approval of two of our leading HMO ingredients in China, we are now able to offer two very important HMOs to the domestic infant nutrition market."

HMOs are a powerful emerging ingredient capturing increasing attention across the health and nutrition space due to recent technological advancements and a growing bank of scientific evidence showing their potential benefits, modes of action and applications. An important component of human breast milk, HMOs have demonstrated to play a fundamental role in infant health by supporting immune function, gut health and potentially cognitive development. ^{i, ii, iii, iv}

As a leader in HMO research, development and production, dsm-firmenich is continuously pioneering advancements in this field and expanding its offering across the early life nutrition and dietary supplement markets.

The company's science-backed GlyCare™ HMO portfolio is already available for use in more than 160 countries worldwide.

About dsm-firmenich
As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world's growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life™ every day, everywhere, for billions of people.
www.dsm-firmenich.com

Forward-looking statements
This press release may contain forward-looking statements with respect to dsm-firmenich's future (financial) performance and position. Such statements are based on current expectations, estimates and projections of dsm-firmenich and information currently available to the company. dsm-firmenich cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. dsm-firmenich has no obligation to update the statements contained in this press release, unless required by law. The English language version of this press release prevails over other language versions.

ⁱ Sprenger N, Tytgat HLP, Binia A, Austin S, Singhal A. Biology of human milk oligosaccharides: From basic science to clinical evidence. J Hum Nutr Diet. 2022 Apr;35(2):280-299. doi: 10.1111/jhn.12990.
ⁱⁱ Puccio G, Alliet P, Cajozzo C, Janssens E, Corsello G, Sprenger N et al. (2017). Effects of infant formula with human milk oligosaccharides on growth and morbidity: a randomized multicenter trial. J Pediatr Gastroenterol Nutr 64(4):624-631. DOI:10.1097/MPG.0000000000001520.
ⁱⁱⁱ Berger B, Porta N, Foata F, Grathwohl D, Delley M, Moine D, et al. (2020). Linking human milk oligosaccharides, infant fecal community types, and later risk to require antibiotics. mBio 11(2):e03196-19 [18pp]. DOI:10.1128/mBio.03196-19.
^iv Vandenplas Y, Żołnowska M, Berni Canani R, Ludman S, Tengelyi Z, Moreno-Álvarez A, et al. (2022). Effects of an extensively hydrolyzed formula supplemented with two human milk oligosaccharides on growth, tolerability, safety and infection risk in infants with cow's milk protein allergy: a randomized, multi-center trial (CINNAMON Study Investigator Group). Nutrients 14(3):530 [14pp]. DOI:10.3390/nu14030530.

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