AOAC SPIFAN Stakeholder Panel Meeting Book (September 7, 2019)

Revised SMPR

Criteria

Value

Analytical range

0.12–5.1 b

Limit of detection (LOD) Limit of quantitation (LOQ)

” ”

b

b

”

0.12-1.5 b

Repeatability (RSD r )

”

”

> 1.5 b

80–

0.12-1.5 b

Recovery

90–

96 –

> 1.5 b

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.

9

133 rd Annual Meeting & Exposition | Denver, Colorado | September 6-12, 2019

Response - CEN TC 275

• ISO TC34/WG14 and CEN TC 275/WG9 discussed vitamin D issue at their meeting on July 3-4, 2019 in Bergen, NO • Recommendation was drafted for CEN TC275 to express concerns about fitness for purpose of current standards EN 12821 and ISO 20636 to demonstrate compliance with new regulation in EU. • CEN TC 275 supports letter to European Commission to raise concerns pertaining to problems to realize enforcement of new Regulation, as advised by EC representative at meeting on September 4, 2019. • In the letter to EC it can be recommended to undertake new CEN work to address the issue.

10

133 rd Annual Meeting & Exposition | Denver, Colorado | September 6-12, 2019