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

General Nutrient Introduction and Background

Calciferol is Inactive Calciferol is Converted to 25-hydroxycalciferol (Calcidiol) in Liver Main Circulating Form Calcidiol is Metabolized to 1,25-dihydroxycalciferol (Calcitriol) by the Kidney Main Biologically Active Form

Helps Regulate Calcium and Phosphorus Blood Levels Enables Normal Bone Mineralization Prevents Rickets in Children Prevents Osteomalacia/Osteoporisis in Adults Modulates Neuromuscular and Immune Function Plays a Role in Reducing Inflammation

Plays a Role in Regulating Cell Proliferation, Differentiation and Apoptosis Vitamin D fortification in infant formula is mandated by all Regulatory Bodies

Regulatory Overview

Historical Landscape – at Time of SMPR Publication

Standard

Regulatory Limits

Regulatory Limits †

Codex, Stan 72-1981

1 – 2.5 g/100kcal

0.65 – 1.63 g/100mL

EU 2006/141/EC

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

1.05–2.63 g/100kcal

0.65 – 1.71 g/100mL

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