AOAC SPIFAN Stakeholder Panel Meeting Book (September 7, 2019)
Regulatory aspects
FDA (GRAS) and EFSA (Novel Food) approvals of a number of HMOs available from 2015
HMO
FDA GRAS notification EFSA Novel Food (NF) Permitted Levels
Granted Granted Granted
Granted Granted Granted
4 g/L*
2’-fucosyllactose (2’FL)
Lacto- N- neotetraose (LNnT )
0.6 g/L ‡
1.6 g/L
2’FL / Difucosyllactose (DFL) mixture
Lacto- N- tetraose (LNT) 3’-Sialyllactose (3’SL)
Submitted
Submitted
n.a.
n.a.
Granted
0.23 g/L
Self affirmed GRAS
n.a.
n.a.
6’-Sialyllactose (6’SL)
* 2’FL added alone or in combination with LNnT (ratio 2’FL:LNnT is 2:1) ‡ Added alone or in combination with 2’FL (ratio 2’FL:LNnT is 2:1)
Analysis of HMO
From the very early stage in HMO research analytical tools needed for: • Separation of HMOs • Structural characterization of molecules • Quantification
Challenges to overcome: • Complex mixtures of (very) polar molecules • Highly branched molecules • Multiple isomers present • No intrinsic chromophore present • Laborious sample preparation • Sensitivity, reproducibility, speed of technologies
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