FrieslandCampina Ingredients achieves Chinese MARA approval and US self-affirmed GRAS status for Aequival LNT

26 Jun 2024 --- FrieslandCampina Ingredients has received approval from the Chinese Ministry of Agriculture and Rural Affairs (MARA) for its production strain of Lacto-N-Tetraose (LNT). With this, the company’s Aequival 2’-FL ingredient goes into the final stage of the approval process, opening up possibilities for this human milk oligosaccharide (HMO) to enter the Chinese market.

Once both these ingredients have achieved the “final nutrition fortifier” approval from Chinese authorities, the supplier will become the sole provider of HMOs and galacto-oligosaccharides (GOS) in the country. HMOs are the most abundant solids in breast milk after fat and carbohydrates, whereas GOS’ are prebiotics made up of plant sugars.

The development comes just after the company secured self-affirmed Generally Recognised as Safe (GRAS) status in the US. This approval is the first of a two-step FDA seal, following which the company will be able to offer the gut-supporting benefits of LNT for infant nutrition to US customers.

Early life nutrition market
Cindy Zhao, general manager of FrieslandCampina Ingredients China, says the development is significant for the early life nutrition sector in China and the US. “Both the MARA and self-affirmed GRAS approvals of the production strain of our LNT bring us one step closer to meeting consumers’ increasing demand for premium, gut-supporting infant milk formulas that provide benefits for babies when breastfeeding isn’t an option.”

She adds that the company secured the approvals after a stringent regulatory process. “With a long history in the infant milk formula market, we’re excited to be soon able to provide brands with innovation opportunities to help support infants when they need it most.”

China is the world’s largest infant milk formula market, and therefore, the approvals could allow brands to offer complementary benefits in their products.

Gut health is crucial to infant well-being. Early life gut maturation and development are essential for proper digestion and absorption of nutrients in the body. Research has shown LNT to be beneficial for the gut. LNT is proven to stimulate the growth of Bifidobacteria, reduce attachment of a parasite notorious for causing gut problems and inhibit the growth of group B streptococcus.

Even though the global infant nutrition market is slowing down, companies continue to innovate for infant nutrition to meet the gold standard of breast milk, focusing on gut health and immunity while developing options for infants with specialized needs, particularly for markets like China, where parents have shown a preference for formulas with more HMOs.