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

Regulatory Overview

Current Landscape

Standard

Regulatory Limits

Regulatory Limits †

Codex, Stan 72-1981 EU 2006/141/EC (Repealed 21 Feb 2020)

1 – 2.5 g/100kcal

0.65 – 1.63 g/100mL

1 – 2.5 g/100kcal

0.65 – 1.63 g/100mL

1980 IFA

1 – 2.5 g/100kcal

0.65 – 1.63 g/100mL

FSANZ, Stan 2.9.1 (2020)

1.05–2.63 g/100kcal

0.65 – 1.71 g/100mL

EU 2016/127 (22 Feb 2020)

2 – 3 g/100kcal

1.3 – 1.96 g/100mL

EU 2019/828 (IF) (22 Feb 2020)

2 – 2.5 g/100kcal

1.3 – 1.63 g/100mL

† Conversion factor used: 65kcal/100mL. Codex range is 60-70 kcal/100mL per Codex Stan 72-1981 § 3.1.2.

Regulatory Overview - Impact on Current SMPR

Criteria

Current SMPR Value

Updated SMPR

Analytical range

0.12–5.1 b

0.12–5.1 b

Limit of detection (LOD)

b

b

b

b

Limit of quantitation (LOQ)

0.12 - 1.5 b

0.12-1.0 b

Repeatability (RSD r )

b

> 1.0

> 1.5 b

> 1.0 b,c

0.12 - 1.5 b

80–

0.12-1.0 b

80– 90– 96–

Recovery

> 1.0 b > 1.0 b,c

> 1.5 b

90–

SMPR revisions are needed to meet Vitamin D limits in EU 2016/127 for Infant and Follow On Formula. 0.12 – 5.1 b > 1.0 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 Applicable only to Infant Formula. 95% CI. Reproducibility (RSD R )