dsm-firmenich takes further steps to bring leading HMO portfolio to China

The HMO production strains of dsm-firmenich’s 3’-SL and 6’-SL have already received safety clearance confirmed by the Chinese Ministry of Agriculture and Rural Affairs (MARA) in September 2021. In the next stage, both 3’-SL and 6’-SL NF dossiers will go through a rigorous multi-phase regulatory assessment by CFSA to achieve food additive registration for early life nutrition (ELN) use in China. This development follows the 2021 submission of dsm-firmenich’s 2’-FL and LNnT HMOs as food additives for infant nutrition in China, which are now in the final stages of the food additive approval process.

“The authorization process in China is stringent and highly challenging to navigate, comprising multiple rounds of technical review by scientific and regulatory experts, as well as a rigorous approval process that safeguards the safety and benefit of nutrition fortifiers intended for infants and young children. We continue to take positive strides in the region – first with the favorable progression of our 2’-FL and LNnT nutrition fortifier regulatory submissions, and now the submission of 3’-SL and 6’-SL,” comments Annette Lau, Global Regulatory Affairs Manager ELN at dsm-firmenich.

“Successfully breaking into complex markets, like China, highlights our teams’ unmatched multidisciplinary teamwork, cross-regional approach, regulatory expertise and their unbreakable commitment to advancing the HMO space. This latest progress is set to create significant innovation opportunities in the early life nutrition landscape – and, ultimately, make the unique benefits of HMOs accessible to more infants and young children globally.”

HMOs are powerful emerging ingredients, and important components of human breast milk, that play fundamental roles in infant nutrition and health by supporting gut health, immune function and potentially cognitive development.^1,2,3,4 dsm-firmenich has additional HMOs in the approvals system in China. As a pioneer in HMO research, development and manufacturing, the company continues to drive a new era in HMO innovation, with plans to expand its offering in the early life nutrition and dietary supplement categories across multiple regions worldwide. Currently, dsm-firmenich’s science-backed GlyCare™ HMO portfolio is available for use in more than 160 countries worldwide – leading in market access and the number of HMO approvals globally.

Discover more about the promising science-based benefits of HMOs and how dsm-firmenich’s industry-leading portfolio can elevate your offering. Visit "The Human Nutrition - Hmos for early life" website. 

*Glycom A/S is ultimately controlled by DSM-Fimenich AG, registered in Kaiseraugst, Switzerland.

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.