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