Characterizing Food Additives to Determine Statistical Equivalence

Rising consumer and regulatory concerns are putting pressure on food and beverage makers and their natural ingredient suppliers to produce safer food products. Chemically, many natural ingredients are highly complex formulations with thousands of individual components that are challenging to characterize. When companies need to change formulations to eliminate compounds of concern, they must be able to show that the new formulation has not introduced any unexpected changes in the final product. 

A food manufacturer came to Battelle for help in proving statistical equivalence of their new food product formulation for regulatory purposes. The manufacturer was phasing out an ingredient due to consumer concern and the potential for future regulation. In order to reduce the likelihood that they would need to conduct expensive regulatory studies and resubmit the product for FDA approval, the manufacturer needed to be able to prove that the new product was substantially equivalent to the old product with the exception of the removed ingredient.