AOAC OMA 2021.01 Reviewer Forms (July 25, 2023)

FOR EXPERT REVIEW PANEL USE ONLY NOT FOR DISTRIBUTION (DRM)

• Performance Characteristics and compared to approved SMPR: Analytical Range: 0.23 to 0.86 g/100 g (SMPR 0.2 - 3.0 g/100g) The study director was not able to source MLT materials as the maximum permitted dose of GOS is 0.8 g/100g) In the SLV was shown that the method is applicable in the range 0.2 - 3.0 g/100g. LOQ: i s the SLV is given that the method can accurately determine GOS at a concentration of 0.2 g/100 g and meets LOQ of the SMPR Accuracy/Recovery: Determined in SLV. PS-1 (SRM 1849b) results have been compared to (non- certified) reference value. MLT result w as 2,61 g/100g and (non - certified) reference value is 2,575 g/100g. MLT result of PS-1 is in the acceptable range of the reference value Precision (RSD r ): Infant Formula powder and liquids : 1,4- 4,7%, (SMPR <6%) ;Adult nutritional sample: 9,9% Reproducibility (RSD R ): IFT Formula powder and liquids : 8,1- 11,6%, (SMPR <12%) ;Adult Nutritional sample: 12,1%

ERP Summary/Recommendation(s):

• Does the method meet the approved SMPR? YES for infant formula. Not proven for Adult nutritionals

• Has the method been performing well in the laboratory? YES, the laboratory needs to gain knowledge on GOS to understand and interpret the results and then the method shown good performance.

• Are there any additional feedback on method performance?

• Would you recommend designating this method as a Final Action method to the ERP?

Recommend to move this method AOAC 2021.01 to final action for the determination of total GOS in Infant formula (powder and liquid). Regarding Adult Nutritionals, only one sample was tested for precision and reproducibility. This Sample does not meet requirement on repeatability. This is the same situation as in the SLV also one sample was tested and did not meet repeatability requirement. At that time the ERP concluded that the method was fit for purpose also for AN? Final Comments? The collaborative study was organized with 14 laboratories from 8 different countries globally. Thirteen laboratories were able to successfully analyze six infant formula and one adult nutritional showing clarity and robustness of method . This method is also in process to become equivalent ISO method ISO /CD 7102

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