119 / 159
FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
2
Cons/Weaknesses
Supporting Data
General Comment:
As a first step the samples were screened in duplicate for the presence of the fructans.
Method Optimization:
Performance Characteristics:
Analytical Range: 0.03 – 5.0 g/100g
SMPR : 0.03 – 5.0 g/100g
The method meets the requirements
LOQ: 0.03g/100g
SMPR requirements : ≤ 0.03 g/100g
The LOQ was checked by adding fructans to a placebo infant formula product at the level of 0.03g/100g
reconstituted final product. At this low level recovery is ranging from 90 to 98%.
Accuracy/Recovery: 90- 107 %
SMPR requirements: 90 -110 %
This recovery was measured by spiking 9 different matrices at different levels covering the proposed range
from 0.05 to 5 g/100g reconstituted product.
The 3 raw materials available in the Test Materials Kit were used for this spiking.
Precision (RSD
r
): 2.9 – 5.8 %
SMPR requirements: ≤ 6 %
The samples were analyzed in double on 6 different days by different operators.
Sample
Fructan (g/100g)
RSD
r
%
Adult nutritional powder milk
protein based J4G-00019
0.59
3,2
Adult nutritional RTF high fat
J4G-00980
0.06
8.0
Child formula powder J4G-
00013
0.35
4.5
Child formula powder J4G-
00974
0.28
9.5
FOS-01 Review Forms