Achieving Chinese MARA approval and US self-affirmed GRAS status

Date: 25.06.2024Source: FrieslandCampina Ingredients

FrieslandCampina Ingredients has announced it has received Chinese Ministry of Agriculture and Rural Affairs (MARA) approval of its production strain of Lacto-N-Tetraose (LNT). This step of the approval, which follows the MARA’s approval of the company’s Aequival® 2’-FL ingredient, means that this ingredient will move to the final stage of the approval process, opening the doors for this human milk oligosaccharide (HMO) to be introduced into China – the world’s largest infant milk formula market.

Once both these ingredients have achieved ‘final nutrition fortifier’ approval in China – the next and final step in the approval process – FrieslandCampina Ingredients will become the sole provider of both HMOs and galacto-oligosaccharides (GOS) in China, a unique position which will enable brands to unlock exciting new opportunities to differentiate their products by providing complementary benefits.

The news comes as FrieslandCampina Ingredients’ Aequival® LNT also secures self-affirmed Generally Recognised as Safe (GRAS) status in the US, the first of a two-step FDA approval. Following full FDA approval, the company will be able to provide the gut-supporting benefits of LNT for infant nutrition to customers in the USA. This achievement, coupled with the recent MARA approval in China, solidifies FrieslandCampina Ingredients’ position as a global leader in gut health ingredients.

This approval means that brands will soon be able to combine FrieslandCampina Ingredients’ LNT, 2’-FL and GOS ingredients to increase the diversity of oligosaccharide structures in their formulations, tapping into both the growing interest in infant gut health and the surge in demand for premium infant milk formulas.

Said Cindy Zhao, General Manager, FrieslandCampina Ingredients China: “This news marks a significant milestone for us as a company and 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 brings 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.

“These approvals, secured through a rigorous regulatory process, further highlights FrieslandCampina Ingredients’ status as a reliable and trusted supplier to the early life nutrition market. With a long history in the infant milk formula market, we’re excited to soon be able to provide brands with new innovation opportunities to help support infants at the time they need it most.”  For more visit frieslandcampinaingredients.com

David Cox / IDM

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