SPIFAN Stakeholder Panel (September 23, 2017)

Draft AOAC MCPD SMPR® 2017.XXX; Version 8; July 25, 2017 1 2 Determination of overall 2- and 3-MCPD, 2- and 3- MCPD esters and glycidyl esters in 3 powdered milk, infant and adult/pediatric nutritional formula 4 5 Purpose: AOAC SMPR’s describe the minimum recommended performance characteristics to be 6 used during the evaluation of a method. The evaluation may be an on-site verification, a single- 7 laboratory validation, or a multi-site collaborative study. SMPRs are written and adopted by 8 AOAC Stakeholder Panels composed of representatives from the industry, regulatory 9 organizations, contract laboratories, test kit manufacturers, and academic institutions. AOAC 10 SMPRs are used by AOAC Expert Review Panels in their evaluation of validation study data for 11 method being considered for Performance Tested Methods or AOAC Official Methods of 12 Analysis , and can be used as acceptance criteria for verification at user laboratories. 13 14 Approved by: Stakeholder Panel for Infant Formula and Adult Nutritionals 15 16 Intended Use: Surveillance and monitoring of powdered milk, infant formula, and adult / 17 pediatric formula by trained technicians.

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1. Applicability:

Quantitative analysis of overall contents of 2-MCPD, 3-MCPD and glycidol, resulting from the separate or combined determination of free 2-MCPD and 2-MCPD esters, free 3-MCPD and 3-MCPD esters and glycidyl esters in all forms of infant, adult nutritionals, and/or pediatric

formula (powders, ready-to-feed liquids, and liquid concentrates).

2. Analytical Technique:

Any analytical techniques (more than one technique may be required) that meets the

following method performance requirements is acceptable.

3. Definitions:

Accuracy 1

The closeness of agreement between the average of an infinite number of replicate

measured quantity values and a reference quantity value.

Adult/Pediatric Formula

Nutritionally complete, specially formulated food, consumed in liquid form, which may constitute the sole source of nourishment, made from any combination of milk, soy, rice, whey, hydrolyzed protein, starch, or amino acids, with and without intact protein.

Infant formula

Breast-milk substitute specially manufactured to satisfy, by itself, the nutritional requirements of infants during the first months of life up to the introduction of appropriate complementary feeding 2 , made from any combination of milk, soy, rice, whey, hydrolyzed

protein, starch, and amino acids, with and without intact protein.

1 Corresponds to the VIM definition for “trueness”. 2 Codex Standard 72 – 1981.

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