MCPD-02 Reviewer Forms (July 19, 2018)

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Reviewer 9

Expert Review Panel for Infant Formula and Adult Nutrition (MCPD)

Evaluation of Method MCPD-02

Title: MCPD-02 – 2-Monochloropropanediol (2-MCPD), 3-Monochloropropanediol (3-MCPD) and Glycidol in Infantand Adult/Pediatric Nutritional Formula - Gas Chromatographic /Mass spectrometric (GC/MS) Method

Author: Jan Kuhlmann, SGS Germany GmbH

Reviewer Name:

Summary of Method: The purpose of this report is to document a single-laboratory validation performed for an AOAC Submitted Method: 2-Monochloropropanediol (2-MCPD), ), 3-Monochloropropanediol (3- MCPD) and Glycidol in Infant and Adult/Pediatric Nutritional Formula. Purchasable samples containing the analytes from processing as well as spiked samples served for validation. Further infant and toddler formula test materials originated from a monitoring project on behalf of the German Ministry of Agriculture and Food. Other single samples came from a method validation study organized by the German Federal Institute of Risk Assessment (BfR), from the US Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN) through the course of an interlaboratory comparison and from the Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) test kit II for nutrient testing. The selected test samples were used to determine such parameters as linearity, limit of quantification (LOQ), specificity, precision, analytical range and accuracy. Analytes tested were free 2-MCPD, ester-bound (bound) 2-MCPD, free 3-MCPD, bound 3-MCPD, and bound glycidol. Because powdered and liquid samples are within the scope of the method both classes of matrices were tested for all cited validation parameters.

Method Scope/Applicability: Applicable for determination of the overall contents of free and ester-bound 2-MCPD, free and ester-bound 3-MCPD and ester-bound glycidol in powdered and liquid infant formula and adult nutritionals, in accordance with AOAC SMPR® 2017.017 - Standard Method Performance Requirements (SMPRs®) for Determination of 2- and 3-MCPD, 2- and 3-MCPD Esters, and Glycidyl Esters in Infant and Adult/Pediatric Nutritional Formula.

General comments about the method: This method appears well written. The scope and applicability are expressed; presented results support final conclusions.

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