AOAC SPIFAN Lactoferrin SMPR Review 1-29-20

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AOAC SMPR 2020.XXX; Version 2; January 29, 2020

Method Name:

Determination of bovine lactoferrin in Infant and Adult/

Pediatric 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 should be able to distinguish intact lactoferrin from its hydrolyzed and/or

degraded forms.

2. Analytical Technique:

Any analytical technique that meets the method performance requirements and specified

conditions is acceptable.

3. Definitions: 22 For the purpose of this SMPR, lactoferrin must be in the soluble fraction of reconstituted 23 product (25 g into 200 g Type I water, 40 degrees Celsius).

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, 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)

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

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