Sialyllactose
Both 3'-sialyllactose and 6'-sialyllactose have FDA GRAS notices and EFSA novel-food authorizations for use in infant formula at specified levels; safety data support their inclusion at HMO-mimicking concentrations.
What it is
A naturally occurring human milk oligosaccharide (HMO); 3'- and 6'-sialyllactose are produced by microbial fermentation for use in infant formula.
Bioactive added to infant formula and medical foods to mimic the oligosaccharide profile of human breast milk.
Why it's flagged
- use levels controlled by regulation; novel-food status outside infant formula
What regulators actually say
"FDA GRAS Notice Inventory contains accepted notices for 3'-sialyllactose and 6'-sialyllactose."
Regulatory status
United States — FDA
Multiple GRAS notices accepted by FDA (e.g., GRN 766, 879) for sialyllactose in infant formula and other foods.
European Union — EFSA
Authorized novel food under Regulation (EU) 2015/2283 (e.g., 6'-sialyllactose Implementing Reg. (EU) 2021/82).
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