AOAC OMB Final Action Recommendation (December 2019)-2016.14

2016.14 (Jan. 2019) FOS-03 MLT Report FOR ERP USE ONLY DO NOT DISTRIBUTE

Summary The method Fructans in Infant Formula and Adult Nutritionals by Anion-Exchange- Chromatography with Pulsed Amperometric Detection after Enzymatic Treatment received First Action status from AOAC in 2016, becoming method 2016.14. In order to determine repeatability and reproducibility data, a collaborative study was organized, to which 14 laboratories from 11 different countries participated. The study was divided in 2 parts. After having communicated results within expected range on a practice sample (part 1) the participants were invited to analyse 8 blind duplicate samples of infant formula and adult nutritional products (part 2). The majority of the participating laboratories applied modifications to the protocol, especially in terms of chromatographic conditions. Twelve laboratories managed to provide results on time for reporting (see Table below). Out of the 8 samples tested, precision results for 5 samples met the requirements of the Standard Method Performance Requirements (SMPR 2014.002), with RSD r ranging from 2.3 to 5.3 % and RSD R ranging from 5.9 to 11.7 %. The practice sample also met the above requirements, with RSD r and RSD R of 2.5 % and 6.7 % respectively. For the 3 test samples that did not meet the requirements, the precision results ranged from 2.3 to 7.7 % for RSD r and from 12.8 to 15.1 % for RSD R .

MLT Results Summary for Fructans in Infant Formula & Adult Nutritionals by AOAC 2016.14 Requirements (SMPR 2014.002) ≤ 6 % ≤ 12 %

RSD r , %

RSD R , %

Horwitz ratio b

Meets SMPR

Mean, g/100 g

Sample name

n a

SRM 1869

11 (1)

0.204

3.8

5.9

1.2

Yes

Adult nutritional RTF (1)

12 (0)

1.28

7.7

13

3.3

No

Adult nutritional RTF (2)

12 (0)

2.67

3.7

11

3.1

Yes

Infant formula RTF

12 (0)

0.300

2.3

15

3.2

No

Child formula powder

12 (0)

0.275

3.8

8.4

1.7

Yes

Toddler formula powder milk-based

12 (0)

0.209

4.3

9.9

2.0

Yes

Infant formula powder FOS/GOS based

Yes

10 (2)

0.0308

3.6

12

1.7

Infant formula powder milk based

12 (0)

0.264

5.3

15

3.0

No

a Number of laboratories considered in the evaluation (number of laboratories with data removed as outliers). b HorRat is not necessary applicable to methods with indefinite analytes like polymers [12] such as fructans