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Dsm-firmenich announced successful GRAS notifications for three HMO ingredients

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The company's lacto-N-fucopentaose I with 2′-fucosyllactose, as well as hypoallergenic grade 2′-fucosyllactose and lacto-N-neotetraose are now GRAS.

Dsm-firmenich (Kaiseraugst, Switzerland) has announced receipt of “no questions” response letters from the U.S. Food and Drug Administration (FDA) for Generally Recognized as Safe (GRAS) noticesa submitted by its subsidiary, Glycom A/S. The notices were for three human milk oligosaccharide (HMO) ingredients. According to the company’s press release, for the first time globally, lacto-N-fucopentaose I with 2′-fucosyllactose (LNFP-I/2’-FL) can be commercialized in formula for infants and young children, as well as other food applications. Additionally, the company explains that the US is the first market in which an HMO that is a pentasaccharide (LNFP-I) is commercially available. This is contrast to a trisaccharide, such as 2’-FL, or tetrasaccharide, such as lacto-N-neotetraose (LNnT). Dsm-firmenich explains that its hypoallergenic grade 2’-FL and LNnT HMO ingredients are also GRAS for use in exempt hypoallergenic infant formula for term infants that have a cow milk protein allergy.

Regarding LNFP-I/2’-FL, this HMO is GRAS for use in ingredient up to 0.8 g/L in non-exempt term infant formula and formulas for young children, up to 1.2 g/L in other drinks for young children, up to 8.33 g/kg in other foods for infants and young children, as well as a maximum range of 1.0 to 20 g/kg or g/L in a variety of conventional foods. Its hypoallergenic grade 2’-FL and LNnT HMOs, marketed as GlyCare 2FL 9000 HA and GlyCare LNnT 9000 HA, are GRAS for maximum-use levels of 2.4 g/L and 0.6 g/L, respectively.

“The GRAS status of LNFP-I/2’-FL for use in formula for infants and young children, as well as other food applications in the US, is a milestone for the use of this ingredient globally,” said Christoph Röhrig, head of HMO regulatory at dsm-firmenich, in a press release. “What’s more, infants with cow’s milk protein allergies have now the opportunity to benefit from exempt formula supplemented with HMOs. Thanks to the approval for use of hypoallergenic grade 2’-FL and LNnT in the US, more infants are now able to enjoy the unique health benefits of HMOs.”

“We are always looking for ways to enhance our HMO offering to help create brighter lives for babies around the world,” added Marta Miks, senior regulatory & scientific affairs manager at dsm-firmenich. “Currently we are petitioning for exemption of our hypoallergenic grade 2’-FL and LNnT from food allergen labeling requirements of the Food, Drug and Cosmetic Act, as amended by Food Allergen Labeling and Consumer Protection Act (FALCPA). With the FDA’s ‘no questions’ response letter to the GRAS notifications, evaluation of the associated FALCPA exemption can now be completed, which will enable these HMOs to be commercialized in exempt infant formula in the US.”

With the approval of LNFP-I/2’-FL in conventional foods in the US, the GRAS status also creates opportunities HMOs in adult consumers, says Miks.


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