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 (that is 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 formula.
All analytical test methods have some uncertainty. The key factor is understanding method variability in the context of overall variability, which also includes variation in raw materials/ingredients and the manufacturing process. The overall variability must fit within the regulatory limits.
By using existing performance data of recently established international Official Methods/Standards it was shown that for products with a manufacturing target at the midpoint of regulations, 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%. This can cause legal uncertainties.
This work supports a risk management approach that takes into consideration the analytical method capability when establishing regulatory limits for nutrients in infant formulas.

Erik J.M. Konings PhD is Program Manager at Nestlé Research where he provides leadership to global quality, laboratory and regulatory teams to engage in strategic local activities to drive alignment/harmonization of analytical methods and partners with government and non-government organizations in the development of standards for analytical methods. He holds an MSc in Epidemiology and PhD in Health Sciences from Maastricht University, the Netherlands.