Stakeholder Panel Meeting Book - September 6, 2014

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Draft SMPR (Version 2) Method Performance Requirements

Analytical range

1 – 1300*

Limit of Quantitation (LOQ)

≤ 1*

Recovery

90‐110%

*μg /100 g reconstituted final  product. a) ‘ready‐to‐feed” liquids “as  is” b) reconstituted powders (25  g into 200 g of water); and  c) liquid concentrates diluted  1:1 by weight.

Repeatability (RSD r ) 1-100

≤ 8% ≤ 5%

>100

Reproducibility (RSD R ) 1-100

≤ 15% ≤ 10%

>100

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Stakeholder Comments Summary of comments

Joseph Schierle (DSM Nutritional Products) 1) Questions the need for separation of  cis isomers of α‐carotene from those of β‐ carotene. 2) Suggests adding zeaxanthin to the scope. 3) Questions the need for a low LOQ of 1 μg/100 g. 4) Comments that the proposed repeatability and reproducibility numbers are very  challenging. Neal Craft (Craft Technologies, Inc.) 1) Proposes quantifying  cis and  trans isomers of lutein. 2) Proposes adding zeaxanthin to the scope. 3) Proposes making definitions of lutein and lycopene more specific. 4) Suggests that methods specific to xanthophylls or carotenes can be submitted.