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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