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

General Nutrient Introduction and Background

Vitamin B 12 present in infant formula as: naturally occurring forms (from raw materials): hydroxycobalamin, methylcobalamin, adenosylcobalamin cyanocobalamin (from fortification) Regulatory requirements need the inclusion of natural amounts in the ingredients as well as the added cyanocobalamin. Applicability statement: Determination of vitamin B12 in all forms of infant, adult, and/or pediatric formula (powders, ready-to-feed liquids, and liquid concentrates). Vitamin B12 is defined as cobalt-containing corrinoids with the biological activity of cyanocobalamin such as cyanocobalamin, aquocobalamin, methylcobalamin and adenosylcobalamin

Regulatory Overview

Origine

Product

Target population Min Max GUL Unit

Codex

Infant formula Follow-up FSMP Infant formula Follow-on

0 – 6 months 6 – 12 months

0.1 0.15

- -

1.5 -

µg/100 kcal

EU

0.5

0.1

0 – 6 months 6 – 12 months

-

FSMP FSMP

µg/100 kcal

0.7 0.5 0.7

0 – 1 year >1 year

0.1 0.07

FSMP

-

USA

Infant formula Follow-up

0 – 6 months 6 – 12 months

0.1 0.5

-

-

µg/100 kcal

• Powdered formulae: ± • Liquid formulae: ±

-

100 ml

-2000 kcal/day; products 1-

-

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