AOAC SPIFAN Nutrients ERP Report (December 7, 2022)

VOTE: Motion – To recommended method for First Action Official Methods SM status Tom Vennard motioned Brendon Gill second Vote: 1 st Vote: 7 Yes/1 No/1 Abstain (Abbott Nutrition) 2 nd Vote: 7 Yes/1 No/1 Abstain (Abbott Nutrition)

RECOMMENDATION: 1. Additional system suitability criteria including: o Calibration (r2 and residual of each calibration level) o Chromatographic (resolution and asymmetry) 2. Augmenting the safety statement to clearly describe the risks of TMCS and consider adding statement to use TMCS in hood (per SDS sections 5.2 and 7.1) 3. Utilize the term trimethylchlorosilane in future publications Additional comments: 1) Section 4.9 System suitability: This CM62 contains Fluoride at concentration of 1.6 mg/kg, about 160 ug/100g. The SMPR requirement for this level is 90-110% recovery and less than 5% in RSDr. In this regard, the 15% level specified in the system suitability for the deviation from the nominal value and for the relative standard seems too wide. 2) In the specificity requirement, 2.5% in RT is used as a limit. When this 2.5% limit is used to assess the extra peaks in Figure 5, it seems that both the adjacent peaks (RT 9.434 min and RT 9.853 min) are within the 2.5% limit of the fluoride peak (RT 9.626 min). I am wondering how this 2.5% limit was established as the specificity limit in RT.

Motion to approve recommendations: Tom Vennard motioned & Brendon Gill second Abstain – FrieslandCampina

REVIEW OF METHODS: HMO

CODIFICATION: HMO-02 METHOD TITLE: Determination of Seven Human Milk Oligosaccharides (HMO) in Infant Formula and Adult Nutritionals REVIEWERS: Yannis Vrasidas & Philip Haselberger VOTE: Motion - To recommended method for First Action Official Methods SM status Yannis Vrasidas motioned Philip Haselberger second Vote: 9 Yes/0 No/1 Abstain RECOMMENDATION/COMMENTS: 1. 6’-SL does not meet LOQ in soy matrices 2. DFL does not meet LOQ in extensively hydrolyzed formula and bovine formula with FOS, but it is still within proposed analytical range. 3. Potential high bias for LNnT and LNT in Elemental formulas at low concentrations (may impact effective LOQ in that matrix) 4. DFL may not meet LOQ in formulas containing polydextrose