Fucosyllactose
2'-Fucosyllactose is GRAS in the US (multiple GRN notices) and authorized as novel food in the EU for infant formula and other applications. EFSA has evaluated several 2'-FL strains and concluded safety at proposed use levels.
What it is
Human milk oligosaccharide (HMO), most commonly 2'-fucosyllactose (2'-FL), produced by microbial fermentation.
Bioactive prebiotic added to infant formula and other foods to mimic HMOs in human milk.
What regulators actually say
"GRAS Notice 000571 - 2'-O-fucosyllactose (2'-FL) - FDA had no questions on the GRAS status."
"EFSA Scientific Opinion on the safety of 2'-O-fucosyllactose as a novel food ingredient pursuant to Regulation (EC) No 258/97."
Regulatory status
United States — FDA
GRAS (e.g., GRN 000571, GRN 000650 for 2'-fucosyllactose).
European Union — EFSA
Authorized as novel food under Regulation (EU) 2015/2283; multiple EFSA opinions confirm safety for infant formula use.
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