MCPD-02 Reviewer Forms (July 19, 2018)

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Reviewer 8 Expert Review Panel for Infant Formula and Adult Nutrition (MCPD)

Evaluation of Method: MCPD-02

Title: 2- Monochloro propanediol (2- MCPD), 3- MonoChloropropane diol (3- MCPD) and

Glycidyl in infant and adult/pediatric nutritional formula.

Author: Jan Kuhlmann, SGS Germany Gmbh

Reviewer Name:

Summary of Method : Free and ester bound analytes are extracted from powder, liquid test samples by

Liquid-liquid extraction techniques and free analytes are determined and measured by GCMS.

Method Scope/Applicability: Yes, the method supports the applicability of SMPR as analysis of 2- and 3-

MCPD and glycidyl esters both in bound and free forms were quantified in various forms like powder, liquid

and liquid concentrate of pediatric nutritional formula.

General comments about the method: Method is in accordance with SMPR and it is the detailed approach

for Quantitative analysis of fatty acids.

Method Clarity: Methodology is clearly explained for both powder and liquid samples.

Method Safety Concerns: Safety concerns have been specified.

Pros/Strengths: • Met the requirements of SMPR • Definitions as mentioned in the SMPR were well defined and evaluated

• Extraction procedure is in detail for all forms of Infant and adult pediatric nutritional formulae

• Tables for the method requirements have been well tabulated along with chromatograms

• All the recommendations have been addressed.

Cons/Weaknesses Extraction procedure can be simplified.

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