Stakeholder Panel Meeting Book - September 6, 2014

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Stakeholder Comments Responses to comments

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.

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Stakeholder Comments Responses to comments

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.