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Codex, Stan 72-1981 EU 2006/141/EC (Repealed 21 Feb 2020)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 )
Made with FlippingBook Annual report