Identification of fit-for-purpose analytical methods for infant formula compliance
The composition of infant formulas is strictly regulated and rigorously tested by official control bodies. Occasionally, competent authorities find deviations between test results vis-à-vis regulatory parameters. One reason for the discrepancies is the use of different analytical methods.
To ensure products meet the highest standards, the global infant formula industry works to ensure a thorough understanding of the capability of an analytical method (i.e. the ability of a method to produce test results within the regulatory limits) as an additional key parameter when establishing compositional criteria for nutrients in infant formulas.
We acknowledge that all analytical test methods have some uncertainty. The key factor is understanding method variability in the context of the overall variability, which also includes variation in raw materials/ingredients and the manufacturing process. The overall variability must fit within the regulatory limits.
Recently, a cross industry group of experts performed an innovative study using existing performance data to identify suitability criteria for compliance testing. The capability of an analytical method was defined and calculated for state-of–the-art internationally recognised reference methods to establish the percentage of deviations from regulatory requirements. Compositional requirements for infant formulas (including foods for special medical purposes intended for infants) in different countries were also reviewed.
The findings showed that the analytical method capability for vitamins A, B12, D and folic acid are of concern in relation to the regulatory requirements in countries such as China, EU member states, Pakistan, Russia, Singapore, South Africa, and Thailand. In addition, a deviation was observed regarding vitamin D in Europe for products with a manufacturing target at the midpoint of regulations. In this case the probability of obtaining an analytical result outside the regulatory requirements due to analytical variation of the method alone can be as high as 19%, which can cause legal uncertainties.Konings-et-al-Food-Control