MCPD-02 Reviewer Forms (July 19, 2018)

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Reviewer 3 Expert Review Panel for Infant Formula and Adult Nutrition (MCPD)

Evaluation of Method ____MCPD-02___________

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

Author: SGS (no authors listed)

Reviewer Name:

Summary of Method: Extraction of fat from powders is performed by Heat Ultrasonic Pressure supported Solvent Extraction (HUPsSE). This procedure extracts both free and bound (esterified) 2-MCPD, 3-MCPD, and glycidol. The single extract is partitioned into an organic phase and an aqueous phase. 2-MCPD esters, 3-MCPD esters, and glycidyl esters are determined in the organic phase by the AOCS Cd 29b-13 method. Free 2-MCPD and 3-MCPD are determined in the aqueous phase by a separate procedure. Extraction of fat from liquid samples is performed by the Rose-Gottlieb procedure. 2-MCPD esters, 3-MCPD esters, and glycidyl esters are determined in the extracted fat by the AOCS Cd 29b-13 method. Free 2- MCPD and 3-MCPD are determined in a separate aliquot of liquid sample by a separate procedure.

Method Scope/Applicability:

Liquid and powdered infant formula and pediatric/adult nutritionals

General comments about the method:

Heat Ultrasonic Pressure supported Solvent Extraction (HUPsSE) appears to be a very efficient way to extract both free and bound (esterified) forms of all analytes. However, it’s only applicable to powders. A different extraction procedure (Rose-Gottlieb) needs to be used for liquid samples. Determination of 2- MCPD esters, 3-MCPD esters, and glycidyl esters in the extracted fat (or organic phase from HUPsSE) is performed by an officially recognized method (AOCS Cd 29b-13). The procedure for the separate determination of free 2-MCPD and 3-MCPD has also been properly validated. Overall, the entire proposed method is of high quality, scientifically sound, and properly validated.

Method Clarity:

The method would benefit from proofing for English grammar and syntax.

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