SPIFAN Stakeholder Panel (March 15, 2017)

• Wyeth/Nestle has developed a whey protein analysis method using SDS-CGE responding to the need of the Chinese regulation of GB 10765-2010 for “milk EDVHG ILUVW DJH LQIDQW IRUPXODV WKH FRQWHQW RI ZKH\ SURWHLQ VKRXOG EH • ´ • The method is innovative (no similar method for infant formulas published or used before); a single lab validation by Wyeth/Nestle and an MLT with 4 qualified Chinese government labs have been finished, and the results are promising. • A linearity test by Wyeth/Nestle, 3 levels spike-recovery tests with 4 labs, and precision test with repeatability, intermediate precision and reproducibility by 4 labs were done following combined GB guidelines and AOAC requirements. QRWH QRW DOO YDOLGDWLRQ SDUDPHWHUV DUH WHVWHG VLQFH WKH PHWKRG LV QRW D TXDQWLILFDWLRQ PHWKRG EDVHG RQ D FDOLEUDWLRQ FXUYH EXW RQ DUHD QRUPDOL]DWLRQ . • Although an officer has commented that fit for purpose methods proposed by reputable manufacturers should be considered, the method still needs to be submitted via a Chinese government lab. Whey protein analysis method using SDS-CGE

March 14, 2017

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Summary of Method Validation Results for Whey Protein Analysis Using SDS-CGE(1) Parameter Acceptance criteria (SPIFAN/SMPR) Results Accuracy The % recovery must lie within the range 95% - 105% of theoretical % Recovery Range 97.6% - 102.2% in 3 levels and in 4 labs Precision – Repeatability %RSD ” 3.0% for whey protein g/100 g protein 0.2% – 2.1% RSD in 4 labs for 4 different infant formula samples Precision- Intermediate Precision %RSD ” 3.0% for whey protein g/100 g protein 0.3% - 2.2% RSD in 4 labs for 4 different infant formula samples Precision – Reproducibility %RSD ” 6.0% for whey protein g/100 g protein 0.9% - 3.8% RSD in 4 different labs for 21 different infant formula samples

March 14, 2017

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