The key to food contact approval for substances coming into contact with foodstuffs via packaging, utensils, or handling materials is proper calculation of the amount of the substance that actually enter into the food. Proper testing using FDA-specified test protocols or (in the absence of actual extraction testing) calculation of the amount of materials entering the food is the means to address this issue. The answer to this question will determine whether the food contact material is considered a "food additive" or not.