453 / 620
Table 4
Product
SPIFAN Code
Analyte
Nr. labs (n)
Conc. Level
µg/kg RTF
RSD
R
REQUIREMENTS SMPR
Conc. Level
(µg/100g)
RSD
R
Infant Pwd Milk Part Hyd
1172572116
Cr
8
<< PLOQ
N/A
X
≤ Z %
Adult Powder Low Fat
00394RF00
Cr
8
48
4.7
Adult Pwd Milk
11750017V3
Cr
7
16
12.0
Child Formula Pwd
00412RF00
Cr
7
30
9.2
Cr
all
< 15%
Infant Elemental Pwd
00403RF00
Cr
7
24
13.0
Adult RTF HP
00414RF00
Cr
8
130
8.1
Adult RTF HF
00406RF00
Cr
8
140
5.8
MEAN RSD(R)
8.8
Infant Pwd Milk Part Hyd
1172572116
Mo
8
20
6.7
Adult Powder Low Fat
00394RF00
Mo
8
63
3.1
Adult Pwd Milk
11750017V3
Mo
7
33
7.9
Mo
all
< 15%
Child Formula Pwd
00412RF00
Mo
8
30
4.6
Infant Elemental Pwd
00403RF00
Mo
8
18
7.9
Adult RTF HP
00414RF00
Mo
7
150
3.0
Adult RTF HF
00406RF00
Mo
8
190
3.8
MEAN RSD(R)
5.3
Infant Pwd Milk Part Hyd
1172572116
Se
8
27
2.5
Adult Powder Low Fat
00394RF00
Se
8
30
7.2
Adult Pwd Milk
11750017V3
Se
8
24
6.1
Child Formula Pwd
00412RF00
Se
8
24
7.3
Se
all
< 15%
Infant Elemental Pwd
00403RF00
Se
8
23
9.3
Adult RTF HP
00414RF00
Se
8
93
8.1
Adult RTF HF
00406RF00
Se
8
133
5.0
MEAN RSD(R)
6.5
Infant Pwd Milk Part Hyd
1172572116
Na
5
not relevant
7.3
Adult Powder Low Fat
00394RF00
Na
5
not relevant
7.6
Adult Pwd Milk
11750017V3
Na
5
not relevant
6.5
Na
all
< 8%
Child Formula Pwd
00412RF00
Na
5
not relevant
7.1
Infant Elemental Pwd
00403RF00
Na
5
not relevant
6.5
Adult RTF HP
00414RF00
Na
5
not relevant
7.0
Adult RTF HF
00406RF00
Na
5
not relevant
7.7
MEAN RSD(R)
7.1
Infant Pwd Milk Part Hyd
1172572116
Mg
5
not relevant
6.9
Adult Powder Low Fat
00394RF00
Mg
5
not relevant
8.0
Adult Pwd Milk
11750017V3
Mg
5
not relevant
6.8
Mg
all
< 10%
Child Formula Pwd
00412RF00
Mg
5
not relevant
16.1
Infant Elemental Pwd
00403RF00
Mg
5
not relevant
6.2
Adult RTF HP
00414RF00
Mg
5
not relevant
7.5
Adult RTF HF
00406RF00
Mg
5
not relevant
7.5
MEAN RSD(R)
8.4
Infant Pwd Milk Part Hyd
1172572116
P
5
not relevant
7.4
Adult Powder Low Fat
00394RF00
P
5
not relevant
8.7
Adult Pwd Milk
11750017V3
P
5
not relevant
8.6
Child Formula Pwd
00412RF00
P
5
not relevant
7.1
P
all
< 8%
Infant Elemental Pwd
00403RF00
P
5
not relevant
4.8
Adult RTF HP
00414RF00
P
5
not relevant
4.9
Adult RTF HF (
falling apart
)
00406RF00
P
5
not relevant
9.7!
MEAN RSD(R)
6.9
Infant Pwd Milk Part Hyd
1172572116
K
5
not relevant
6.0
Adult Powder Low Fat
00394RF00
K
5
not relevant
6.2
Adult Pwd Milk
11750017V3
K
5
not relevant
4.8
Child Formula Pwd
00412RF00
K
5
not relevant
5.4
K
all
< 8%
Infant Elemental Pwd
00403RF00
K
5
not relevant
4.9
Adult RTF HP
00414RF00
K
5
not relevant
4.5
Adult RTF HF
00406RF00
K
5
not relevant
5.3
MEAN RSD(R)
5.3
Infant Pwd Milk Part Hyd
1172572116
Ca
5
not relevant
4.7
Adult Powder Low Fat
00394RF00
Ca
5
not relevant
5.9
Adult Pwd Milk
11750017V3
Ca
5
not relevant
5.2
Ca
all
< 8%
Child Formula Pwd
00412RF00
Ca
5
not relevant
6.5
Infant Elemental Pwd
00403RF00
Ca
5
not relevant
5.0
Adult RTF HP (
falling apart
)
00414RF00
Ca
5
not relevant
13.4!
Adult RTF HF (
falling apart
)
00406RF00
Ca
5
not relevant
43.9!
MEAN RSD(R)
5.4
Infant Pwd Milk Part Hyd
1172572116
Mn
6
not relevant
5.7
Adult Powder Low Fat
00394RF00
Mn
6
not relevant
3.8
Adult Pwd Milk
11750017V3
Mn
6
not relevant
4.0
Child Formula Pwd
00412RF00
Mn
6
not relevant
3.2
Mn
all
< 10%
Infant Elemental Pwd
00403RF00
Mn
6
not relevant
3.4
Adult RTF HP (
falling apart
)
00414RF00
Mn
6
not relevant
23.5!
Adult RTF HF (
falling apart
)
00406RF00
Mn
6
not relevant
23.9!
MEAN RSD(R)
4.0
Infant Pwd Milk Part Hyd
1172572116
Fe
6
not relevant
3.5
Adult Powder Low Fat
00394RF00
Fe
6
not relevant
5.2
Adult Pwd Milk
11750017V3
Fe
6
not relevant
5.5
Fe
all
< 10%
Child Formula Pwd
00412RF00
Fe
6
not relevant
4.3
Infant Elemental Pwd
00403RF00
Fe
6
not relevant
4.9
Adult RTF HP (
falling apart
)
00414RF00
Fe
6
not relevant
11.6!
Adult RTF HF (
falling apart
)
00406RF00
Fe
6
not relevant
8.4!
MEAN RSD(R)
4.7
Infant Pwd Milk Part Hyd
1172572116
Cu
6
not relevant
2.3
Adult Powder Low Fat
00394RF00
Cu
6
not relevant
4.1
Adult Pwd Milk
11750017V3
Cu
6
not relevant
4.0
Cu
all
< 10%
Child Formula Pwd
00412RF00
Cu
6
not relevant
2.5
Infant Elemental Pwd
00403RF00
Cu
6
not relevant
8.4
Adult RTF HP
00414RF00
Cu
6
not relevant
4.7
Adult RTF HF
00406RF00
Cu
6
not relevant
3.6
MEAN RSD(R)
4.2
Infant Pwd Milk Part Hyd
1172572116
Zn
6
not relevant
2.3
Adult Powder Low Fat
00394RF00
Zn
6
not relevant
5.9
Adult Pwd Milk
11750017V3
Zn
6
not relevant
5.4
Zn
all
< 10%
Child Formula Pwd
00412RF00
Zn
6
not relevant
2.3
Infant Elemental Pwd
00403RF00
Zn
6
not relevant
6.0
Adult RTF HP (
falling apart
)
00414RF00
Zn
6
not relevant
15.9!
Adult RTF HP (
falling apart
)
00406RF00
Zn
6
not relevant
9.7!
MEAN RSD(R)
4.4
Global Mean %
6.0
Precision - reproducibility
SPIFAN ERP Checklist v 1.0
MTE-02 MEF Form
FOR ERP USE ONLY
DO NOT DISTRIBUTE