MCPD-02 Reviewer Forms (July 19, 2018)

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Reviewer 1 Expert Review Panel for Infant Formula and Adult Nutrition (MCPD)

Evaluation of Method: MCPD-02 (SGS Germany)

Title: 2-Monochloropropanedio (2-MCPD), 3-Monochloropropanedio (3-MCPD), and Glycidol in Infant and Adult/Pediatric Nutritional Formula

Author: SGS Germany (Jan Kuhlmann)

Reviewer Name:

Summary of Method:

• Extraction of fat content from liquid and powder formula samples by Heat-Ultrasonic-Pressure- supported-Solvent-Extraction (HUPsSE) • Determination of free and bound analytes in fat extracts using indirect (GC-MS) analysis (alkaline transesterification – based on AOCS Cd 29b-13)

Method Scope/Applicability:

• Applicable to powder and liquid samples, infant and adult formulas • Method encompasses the determination of both free (2- and 3-MCPD) and bound (2- and 3- MCPD esters and glycidyl esters) analytes

General comments about the method:

• Separate extraction procedure for liquid samples (Rose Gottlieb) – additional text in Section A describes modification of samples (either lyophilization of liquid samples or preparation of powdered samples with water) so that a single extraction procedure can be used for all formula samples • SLV includes data comparison of powdered and liquid samples

Method Clarity:

• Procedural and safety details edited/added; procedure written in individual steps for added clarity

Method Safety Concerns:

• None

Pros/Strengths:

1