Challenge to evaluate regulatory compliance for nutrients in infant formulas with current state-of-the-art analytical reference methods

摘要

Infant formulas are strictly regulated and rigorously tested for compliance. Recently, new official analytical methods/standards have been established for nutrient analyses in these product categories through the Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN), governed by AOAC INTERNATIONAL. Many of these methods have been adopted or are in the process of being adopted as reference methods by Codex Alimentarius. The purpose of this paper is to assess the ability of these cutting-edge analytical methods to deliver acceptable results in the context of established regulatory limits for nutrients in food standards and regulations. For this evaluation, the analytical method variability is considered as one of the three main sources of overall process variability, which also includes variation in raw materials/ingredients and the manufacturing process.