dsm-firmenich, the leading innovator in health, nutrition and beauty, has recently confirmed its plan to expand its human milk oligosaccharide (HMO) portfolio in China with 2 new ingredient submissions to the China National Center for Food Safety Risk Assessment (CFSA) and National Health Committee (NHC).
Glycome A/S, controlled by DSM-Firmenich AG, has submitted Nutrition Fortifier (NF) dossiers for its GlyCare™ 3’-sialyllactose (3’-SL) and 6’-sialyllactose (6’-SL) ingredients – joining the registration process of its 2’-fucosyllactose (2’-FL) and lacto-N-neotetraose (LNnT) HMOs.
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.
According to Annette Lau, Global Regulatory Affairs Manager ELN at dsm-firmenich, “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.”
“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,” added Lau.
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.
dsm-firmenich also has additional HMOs in the approval 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.
In a separate development, dsm-firmenich has initiated legal action for patent infringement against 2 Chinese companies – Zhejiang Shengda Bio-pharm Co., Ltd. – a biotin supplier – and Anhui Shengda Bio-pharm Co., Ltd., a.k.a. Anhui Shengda Bio-engineering Co., Ltd. – a biotin intermediate manufacturer. Both companies are collectively known as ‘Shengda’.
dsm-firmenich claimed that Shengda’s production of a key biotin intermediate at its Anhui site is unlawful using dsm-firmenich patented technology. dsm-firmenich has petitioned the court in Anhui Province to order Shengda to cease using the patented technology and pay compensation for the infringement.
Earlier on, dsm-firmenich won a case against another Chinese biotin manufacturer for similar infringement.
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