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Draft AOAC SMPR 2017.XXX; Version 2; March 15, 2017
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Determination of free 2- and 3-MCPD, 2- and 3- MCPD esters and glycidyl esters in powdered
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milk, infant and adult/pediatric nutritional formula
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Purpose:
AOAC SMPR’s describe the minimum recommended performance characteristics to be
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used during the evaluation of a method. The evaluation may be an on-site verification, a single-
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laboratory validation, or a multi-site collaborative study. SMPRs are written and adopted by
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AOAC Stakeholder Panels composed of representatives from the industry, regulatory
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organizations, contract laboratories, test kit manufacturers, and academic institutions. AOAC
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SMPRs are used by AOAC Expert Review Panels in their evaluation of validation study data for
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method being considered for
Performance Tested Methods
or AOAC
Official Methods of
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Analysis
, and can be used as acceptance criteria for verification at user laboratories.
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Approved by:
Stakeholder Panel for Infant Formula and Adult Nutritionals
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Intended Use:
Surveillance and monitoring of powdered milk, infant formula, and adult /
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pediatric formula by trained technicians.
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1.
Applicability:
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Quantitative analysis of free 2- and 3-MCPD, 2- and 3- MCPD esters (expressed as 2- and 3-
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MCPD, respectively) and glycidol and glycidyl esters (expressed as glycidol) in all forms of
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infant, adult nutritionals, and/or pediatric formula (powders, ready-to-feed liquids, and
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liquid concentrates).
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2.
Analytical Technique:
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Any analytical technique that meets the following method performance requirements is
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acceptable.
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3.
Definitions:
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Accuracy
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The closeness of agreement between the average of an infinite number of replicate
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measured quantity values and a reference quantity value.
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Adult/Pediatric Formula
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Nutritionally complete, specially formulated food, consumed in liquid form, which may
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constitute the sole source of nourishment, made from any combination of milk, soy, rice,
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whey, hydrolyzed protein, starch, and amino acids, with and without intact protein.
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Infant formula
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Breast-milk substitute specially manufactured to satisfy, by itself, the nutritional
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requirements of infants during the first months of life up to the introduction of appropriate
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complementary feeding
2 ,made from any combination of milk, soy, rice, whey, hydrolyzed
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protein, starch, and amino acids, with and without intact protein.
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Limit of Detection (LOD)
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The smallest amount or concentration of an analyte that can be estimated with acceptable
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reliability. Determined as: LOD = blank mean + 3 standard deviations of ten independent
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analyses of blank or blank spiked at low level (to be agreed upon by Study Directors) (if
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Corresponds to the VIM definition for “truness”.
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Codex Standard 72 – 1981.