AOAC SPIFAN Stakeholder Panel Meeting Book (March 12, 2020)

Required Method Precision

At the 95% Confidence Level (standard deviation is 1/4 th of regulatory range) The performance of method precision required to meet the Delegated Regulation (EU) 2016/127 RSD R = For Follow On Formula: RSD R At the 99% Confidence Level (standard deviation is 1/6 th of regulatory range) The performance of method precision required to meet the Delegated Regulation (EU) 2016/127 RSD R = For Follow On Formula: RSD R

Proposed SMPR – Option 1

Criteria

Value

Analytical Range Limit of Detection Limit of Quantitation

0.12–5.1 µg/100g b

b

b

0.12–1.5 µg/100g b >1.5 µg/100g b 0.12–1.5 µg/100g b

Repeatability (RSD r )

80– 90–

Recovery

>1.5 µg/100g b

Leave SMPR as is Meets current Codex Stan 72-1981, FSANZ Stan 2.9.1, GB, IFA Not fit-for-purpose for Delegated Regulation (EU) 2016/127 for Infant or Follow On Formula Address non-compliance risk via other avenues (discussion papers, publications, etc) Reproducibility (RSD R ) 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.