Stakeholder Comments
Responses to comments
7
Separation of
cis
isomers of α‐carotene from those of β‐carotene
Typically alpha‐carotene is found in infant formula in minor concentrations relative to
beta‐carotene, and if the separation of
cis
isomers is very challenging then it might be
best to remove this requirement.
Separation of
cis
and
trans
isomers of lutein
The applicability statement can be updated to include
cis
isomers of lutein, as the all‐
trans
form may be preferentially absorbed or more biologically active.
Inclusion of zeaxanthin in the scope
While we recognize the nutritional relevance of zeaxanthin, no manufacturers currently
have plans to add it to their formulas. Separation of lutein from zeaxanthin is included
in the system suitability criteria of the SMPR.
Stakeholder Comments
Responses to comments
8
LOQ
The LOQ and range were based on current levels of carotenoids in infant formula and
adult nutritionals. While 1 mcg/100 g is very low, it is not far below the minimum 42
mcg/L (4.2 mcg/100 g) for lutein specified in the FSANZ regulations.
Repeatability and Reproducibility
These targets are demanding, and even the best methods may not meet the criteria for
every analyte. With other nutrients in the SPIFAN process, we have also set the bar very
high and have been impressed with the methods submitted.
