AOAC SPIFAN Stakeholder Panel Meeting Book (March 12, 2020)
Proposed SMPR – Option 2
Criteria
Value
Analytical range
0.12–5.1 b
Limit of detection (LOD)
b
Limit of quantitation (LOQ)
b
0.12-1.5 1. 0 b > 1.5 1. 0 b 0.12-1.5 1. 0 b
Repeatability (RSD r )
80–
Recovery
> 1.5 1. 0 b
90–
96 – 104%
Reproducibility (RSD R ) 5.6% a Concentrations apply to (1) “ready-to-feed” liquids “as is”; (2) reconstituted powders (25 g into 200 mL water); and (3) liquid concentrates diluted 1:1 by weight. b µg/100 g expressed separately as vitamin D 2 and vitamin D 3 in reconstituted final product. Amend SMPR for Delegated Regulation (EU) 2016/127 for Infant Formula and apply to all Matrices Adopt 95% (or 99%) CI Current state-of-the art methods may not to meet RSD r and RSD R requirements
Proposed SMPR – Option 3
Criteria
Value
Analytical range
0.12–5.1 b
Limit of detection (LOD) Limit of quantitation (LOQ)
b
b
0.12-1. 0 b > 1. 0 b
Repeatability (RSD r )
(or 3.3%)
> 1. 0 b,c
0.12-1. 0 b
80– 90–
Recovery
> 1. 0 b > 1. 0 b,c
96 – 104%
Reproducibility (RSD R )
> 1. 0
(or 6.5%)
b
> 1.0 b,c a Concentrations apply to (1) “ready-to-feed” liquids “as is”; (2) reconstituted powders (25 g into 200 mL water); and (3) liquid concentrates diluted 1:1 by weight. b µg/100 g expressed separately as vitamin D 2 and vitamin D 3 in reconstituted final product. c For Infant Formula, only. Amend SMPR for all matrices with vitamin D content > 1.0 µg/100 g to align with Delegated Regulation (EU) 2016/127 for Follow On Formula Amend SMPR to specifically address Delegated Regulation (EU) 2016/127 for Infant Formula Adopt 95% (or 99%) CI
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