351: Safeguarding the Quality and Integrity of Food Ingredients: Development of the Food Chemicals Codex (FCC) Monograph for Lactoferrin From Bovine (Bos Taurus) Milk

Introduction

Bovine lactoferrin (LF), a glycoprotein derived from cow’s milk, plays a vital role in immune function and blood coagulation. Glycoproteins are proteins covalently bonded to carbohydrate chains, contributing to their bioactivity. The US FDA has issued “no questions” letters for several Generally Recognized As Safe (GRAS) notices, confirming LF’s GRAS status under specified use conditions. Additionally, LF is recognized as a novel food in the European Union. Given its high value and extensive use in premium products such as infant formula, LF is especially susceptible to economically motivated adulteration (EMA).

Methods

The development of an FCC monograph for LF encompasses identification tests, assay, impurity testing, specific tests, and the establishment of a physical reference standard (RS). Two primary identification methods are included: High-performance liquid chromatography with ultraviolet detection (HPLC-UV), comparing retention time with a USP RS; and Fourier transform infrared spectroscopy (FTIR), providing the spectrum of a USP RS for comparison. Utilizing these two orthogonal analytical methods provides robust protection against EMA, commonly referred to as food fraud, specifically melamine adulteration.

Results

A validated, highly robust, and reproducible HPLC-UV method for identification and quantification of LF has been established. A physical USP Lactoferrin RS helps ensure the quality, purity and identity of the ingredients. Using FTIR as a second identification test helps reduce the risk of melamine adulteration. Distinct melamine peaks were observed in FTIR spectra for LF samples spiked with 5%, 10%, and 33% melamine.

Significance

Adulteration of ingredients used in infant formula has profound economic impacts and poses risks to public health and confidence in food safety. The FCC standards aim to safeguard the safety and integrity of the food ingredients, support public trust, and help support regulatory compliance.

Author: Jian Kong