US GRAS Recognition for Three Human Milk Oligosaccharide (HMO) Ingredients

On August 10, 2023, U.S. health, nutrition and beauty company DSM-firmenich (DSM) officially announced that they have received "no questions" response letters from the U.S. Food and Drug Administration (FDA), indicating the approval of their three new human milk oligosaccharide (HMO) ingredients as Generally Recognized as Safe (GRAS).

lacto-N-fucopentaose I with 2′-fucosyllactose (LNFP-I/2’-FL) can be used in the following amounts:

• Up to 0.8g/L in non-exempt term infant formula and formulas for young children;

• Up to 1.2g/L in other drinks for young children;

• Up to 8.33g/kg in other foods for infants and young children;

• Up to a maximum range of 1 to 20 g/kg or g/L in a variety of conventional foods.

lacto-N-neotetraose (LNnT) and 2′-fucosyllactose (2’-FL) can be used in extensively hydrolyzed or amino acid-based infant formula intended for term infants with cows' milk protein allergy (CMPA).

This approval means that term infants with CMPA have the opportunity to consume infant formula containing HMOs. However, due to the presence of the Food Allergen Labeling and Consumer Protection Act (FALCPA) in the United States, after recognized as GRAS, DSM still needs regulatory authorities to exempt LNnT and 2'-FL from being labeled as allergens. The assessment of the corresponding FALCPA exemption is completed now.

Recommended reading

GRAS stands for "Generally Recognized as Safe," which is an essential category in US food regulation. In simple terms, if a substance has been scientifically evaluated as safe for its intended use through rigorous scientific determination procedures by a panel of qualified experts with experience and expertise, then it is considered GRAS. Food manufacturers can use these GRAS approved ingredients in their new formulations without requiring FDA's approval.

On September 4, 2023, ChemLinked will host a free webinar introducing the different types of GRAS applications, as well as the administrative and technical requirements for GRAS notice. We invite you to register for the webinar by clicking here.