FrieslandCampina’s human milk oligosaccharide ingredient obtains EU approval and GRAS status

09 May 2018 --- FrieslandCampina DOMO’s new human milk oligosaccharide (HMO) ingredient, 2’-fucosyllactose (2’-FL), has been officially certified for use in infant formula in both European and US markets. The ingredient has received EU novel food approval and achieved GRAS (Generally Recognized as Safe) status from the Food and Drug Administration (FDA) in the US. The company reports that these authorizations are an important step forward in the plan of FrieslandCampina to launch its first HMO by the end of the year.

HMOs are non-digestible carbohydrates and are the third most abundant component in human milk after lactose and fat. More than 200 different varieties have currently been identified in human milk, of which 2’-FL is the most prevalent. Recent clinical trials have suggested that 2’-FL plays a key role in protecting and promoting the health of newborn infants, particularly in respect to the immune system, and have shown that the addition of 2’-FL to infant formula is safe and well tolerated. Further evidence has suggested that HMOs can benefit the health of developing infants by supporting digestive and cognitive development.

FrieslandCampina DOMO, like many other companies working with infant nutrition ingredients, always advocates breast feeding. However, when this is not possible, the addition of HMOs to infant formula products marks a significant development in supporting early nutrition.

“We expect HMOs to be the next-generation infant formula drivers, as these are identical to the structures that are found in human milk. In addition, we continue to see consumers focusing on quality assurances for infant formula, which is, for example, visible in the consumer trend towards organic products,” Godert Zijlstra, Business Development Director, FrieslandCampina DOMO, tells NutritionInsight.

“Our 75 years of expertise in infant nutrition were essential in setting up a safe, smooth production process that ensures a continuously high-quality product such as 2’-FL. DOMO is the market leader in oligosaccharides and has an extensive portfolio of infant nutrition ingredients, to which 2’-FL is the perfect addition, helping our customers to develop the next generation of infant formula,” says Aafke Keizer, Managing Director FrieslandCampina DOMO.

2’-FL is the result of a global partnership between FrieslandCampina DOMO and the US-based company Glycosyn, which have combined their expertise to develop new infant nutrition ingredients. 

FrieslandCampina DOMO’s 2’-FL ingredient, which will be marketed under the brand name Aequival, is the first product in a range of HMOs that will be commercially available from the company in the foreseeable future. In addition, a dedicated 2’-FL plant is being built in Italy, allowing large-scale production to take place by the end of this year. Available for the global market at the highest infant formula standards, 2’-FL has been developed using Glycosyn’s patented technology.

“By the end of 2018, our first HMO, Aequival 2’-FL, will be commercially available. After decades of experience in infant nutrition and oligosaccharides, we have embarked on a new and exciting time in the development of breakthrough innovations for our industry,” Zijlstra notes.

“We see Aequival 2’-FL as a starting point for our HMO platform. From our state-of-the-art new facilities, we will be formulating and launching a broad range of HMOs over the next few years to help our customers develop the next-generation infant formulas,” Zijlstra says. “FrieslandCampina DOMO has a global customer base and hopes that revolutionary innovations, such Aequival 2’-FL, can reach infant formulas all over the world. We do see in Asian countries – more specifically China – that consumers pay special attention to highly functional ingredients.”

HMOs are gaining traction in the infant nutrition market. At the end of March, NutritionInsight reported that DuPont Nutrition & Health and Inbiose NV gained regulatory approval of their first HMO ingredient for infant formula in the European market.

By Lucy Gunn