AOAC SPIFAN Stakeholder Panel Meeting Book (March 12, 2020)

AOAC SMPR 2020.XXX; Version 3; February 6, 2020 1 2 Method Name: Determination of bovine lactoferrin in Infant and Adult/Pediatric 3 Nutritional Formula 4 5 6 Approved by: Stakeholder Panel for Infant Formula and Adult Nutritionals 7 Final version date : 8 Effective date: 9 10 Intended Use: Reference method for dispute resolution.

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1. Applicability:

Determination of intact bovine lactoferrin concentration in all forms of infant, adult and /or pediatric formulas (powders, ready-to-feed liquids and liquid concentrates). The method must be able to distinguish intact lactoferrin from its hydrolyzed forms.

2. Analytical Technique:

Any analytical technique that meets the method performance requirements and specified conditions is acceptable. For the purpose of this SMPR, lactoferrin must be in the soluble fraction of: (a) reconstituted powder products (25 g into 200 g Type I water, 40 degrees Celsius), (b) “ready-to-feed” liquids “as is”, or (c) liquid concentrates diluted 1:1 by weight

using water

3. Definitions:

Accuracy 1

The closeness of agreement between the average of an infinite number of replicates measured quantity values and a reference quantity value, if available.

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, and 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.

Limit of Detection (LOD)

The minimum concentration or mass of analyte that can be detected in a given matrix with

no greater than 5% false positive risk and 5% false negative risk.

Limit of Quantitation (LOQ)

The minimum concentration or mass of analyte in a given matrix that can be reported as a

quantitative result.

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

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